Consumer Alerts Tracker

Alerts

160 official-source pages are currently published.

CISA KEV

Oracle E-Business Suite Improper Privilege Management Vulnerability

Oracle E-Business Suite contains an improper privilege management vulnerability that allows an unauthenticated attacker with network access via HTTP to compromise Oracle Payments. Successful attacks of this vulnerability can result in takeover of Oracle Payments.

Known exploited vulnerability Priority 61
CPSC

Flaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire and Burn Hazards

Recalled Flaunt MagSafe Battery Chargers (front view)

This recall involves the Flaunt MagSafe Battery Charger power banks with model number E33A. "FLAUNT" is engraved on the front right side of the power bank and there is a small circular button in the bottom center of the front side of the power bank. The back label of the unit is marked "FLAUNT" and "Model: E33A". The power banks were sold in melon, black, lavender and white. The chargers measure 3 by 2 by 0.25 inche...

Consumer product recall Priority 61
CPSC

Greenworks Tools Recalls 24V and 48V Kobalt Yard Power Tools with USB-C Batteries Due to Risk of Serious Injury from Fire Hazard

Recalled Kobalt yard power tools

This recall involves Kobalt yard power tools, including trimmers, blowers, mowers, chainsaws and pruning saws that use 24V Kobalt-branded batteries with a USB-C charging port. The batteries with a USB-C charging port come in 3.0Ah, 4.0Ah, 5.0Ah, 6.0Ah, and 8.0Ah. The 6.0Ah and 3.0Ah batteries were also sold separately from the tool. Only products with the USB-C batteries are included in the recall. Product Descripti...

Consumer product recall Priority 61
CPSC

Best Buy Recalls Insignia® Gas Ranges Due to Risk of Serious Injury from a Fire Hazard

Recalled Insignia Front Control Gas Range, model number: NS-RGFGSS1

This recall involves Insignia gas ranges with model numbers NS-RGFGSS1 and NS-RGFCGS2. The recalled ranges are stainless steel with five front-knobs on the oven with the "Insignia" label on the bottom of the oven door. A label with the model number can be found on the inside of the range's bottom drawer.

Consumer product recall Priority 61
CPSC

Biometric Gun Safes Recalled Due to Serious Injury Hazard and Risk of Death; Sold Exclusively on Amazon.com by BBRKIN

Recalled BBRKIN and MouTec Biometric Firearm Safe model number QHXP029B

This recall involves BBRKIN and MouTec Biometric Gun Safes with model number QHXP029B. The gray steel safes are used to store firearms and valuables. The safes measure about 14 inches by 12 inches by 57 inches, have one shelf and can store approximately five firearms. The recalled safes have the following serial number range: SQC200034980 - SQC202319171. The serial number is on a label on the lower right corner of t...

Consumer product recall Priority 61
CPSC

Moodooy Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Yuezhang

Recalled Moodooy Adult Portable Bed Rail

This recall involves the Moodooy-branded adult portable bed rail. The bed rail has a white frame with black trim and a black storage pocket. The brand name "Moodooy" and model "F311" are printed on the storage pocket. The bed rail is about 12 inches wide by about 21 inches tall to about 23 inches tall (when extended).

Consumer product recall Priority 61
CPSC

WonderStone Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall Hazard; Violate Mandatory Standard for Infant Walkers; Sold on Walmart.com by Wonder Stone Toys

Recalled WonderStone Infant Walker – green

This recall involves WonderStone-branded Infant Walkers sold in green and pink. The walkers have a gray fabric seat, a white tray with a detachable music box, six wheels, a foot pad and a white hand lever. "Model No: 616" or "Model No: 616-1" is printed on a white label located under the tray.

Consumer product recall Priority 61
CISA KEV

SonicWall SMA1000 Appliances Code Injection Vulnerability

SonicWall SMA1000 Appliances contain a code injection vulnerability which in specific conditions could potentially enable a remote authenticated attacker as administrator to execute arbitrary OS commands.

Known exploited vulnerability Priority 60
CISA KEV

Cisco IOS Cross-Site Request Forgery Vulnerability

Cisco IOS 12.4 contains multiple cross-site forgery vulnerabilities that allows remote attackers to execute arbitrary commands via (1) a certain "show privilege" command to the /level/15/exec/- URI, and (2) a certain "alias exec" command to the /level/15/exec/-/configure/http URI.

Known exploited vulnerability Priority 59
openFDA Medical device

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.

Medical device recall Priority 58
openFDA Medical device

Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolong...

Medical device recall Priority 58
openFDA Medical device

CRE Pro Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

Medical device recall Priority 58
openFDA Medical device

CRE Pro Wireguided 10-12mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

Medical device recall Priority 58
openFDA Drug

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Drug

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Drug recall Priority 58
openFDA Medical device

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

Medical device recall Priority 58
openFDA Medical device

RayCare 2024A SP1. Oncology Information Systems.

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

Medical device recall Priority 58
openFDA Medical device

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medical device recall Priority 58
openFDA Medical device

Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

Medical device recall Priority 58
openFDA Medical device

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Medical device recall Priority 58
openFDA Medical device

Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 7) LACERATION TRAY, Model Number: SUT18660A; 8) GENERAL BIOPSY TRAY, Model Number: MNS5985; 9) LACERATION TRAY, Model Number: DYNDL1351; 10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 11) ARTERIAL LINE TRAY, Model Number: ART600; 12) SUTURE TRAY, Model Number: SUT12260; 13) ER SUTURING TRAY, Model Number: SUT9710C; 14) INCISION & DRAINAGE TRAY, Model Number: ID2060; 15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265; 16) BIOPSY TRAY, Model Number: DYNDH1466; 17) GENERAL BIOPSY TRAY, Model Number: MNS5985; 18) SUTURE SET, Model Number: SUT19665; 19) MYELOGRAM-LF SAFE PACK, Model Number: P124863; 20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 21) LACERATION TRAY, Model Number: SUT18660A; 22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352; 23) BIOPSY PACK, Model Number: DYNDH1699; 24) SUTURE TRAY, Model Number: SUT12260; 25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 26) ARTHROGRAM TRAY, Model Number: SPEC0070B; 27) SUTURING SET, Model Number: SUT4155; 28) SUTURE TRAY, Model Number: SUT16080; 30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213; 31) MYELOGRAM PACK, Model Number: P155615A; 32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Medical device recall Priority 58
openFDA Medical device

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medical device recall Priority 58
openFDA Medical device

Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

Medical device recall Priority 58
openFDA Medical device

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medical device recall Priority 58
openFDA Medical device

Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Model Number: ARTNC217; 6) PRESSURE INJ. CVC INSERTION BUNDLE, Model Number: ECVC1720; 7) DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4815; 8) MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: STCVC04; 9) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 10) ARTERIAL LINE TRAY, Model Number: ART350; 11) CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; 12) UMBILICAL VESSEL INSERTION TRAY, Model Number: UVT980; 13) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; 14) UCLA - FINE NEEDLE BIOPSY, Model Number: P972300A; 15) TRIPLE LUMEN COMPLETE CATH KIT 16CM, Model Number: ECVC825A; 16) 8.5F 4L 20CM CVC + BUNDLE, Model Number: ECVC8640; 17) ULTRA CORE BIOPSY KIT, Model Number: SPEC0291B; 18) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number: ECVC7605; 19) WATERBURY 3L CVC BUNDLE, Model Number: ECVC7330; 20) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; 21) VANTEX 8.5FR 2L 16CM CVC BUNDLE-US, Model Number: ECVC8110; 22) FEMORAL ARTERIAL LINE TRAY, Model Number: ART660A; 23) VANTEX 3L, 7FR, 16CM CVC INSERTION BNDL, Model Number: ECVC5370B; 24) STD, VAN, 3L, 7F, 20CM, KIC, Model Number: A3720KIC; 25) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 26) VANTEX 7FR 3L 20CM CVC BUNDLE W/US, Model Number: ECVC8180; 27) NO CATH DIALYSIS KIT, Model Number: ECVC8595; 28) SOFT TISSUE TRAY, Model Number: DYNDA1954A; 30) LACERATION TRAY WITH LIDOCAINE, Model Number: SUT10830A; 31) LACERATION TRAY, Model Number: SUT10520; 32) VANTEX 7F 20CM 3L CVC BUNDLE, Model Number: CMPV7203LBB; 33) VANTEX 7F 16CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8380B; 34) BIOPSY TRAY, Model Number: MNS7065A; 35) STD, INTRO-FLEX INTRODUCER 8.5F, Model Number: I500BF85; 36) A LINE TRAY, Model Number: ART690; 37) 8.5F 16cm DOUBLE LUMEN CVC BUNDLE, Model Number: ECVC5490; 38) VANTEX 8.5FR 16CM 4L CVC BUNDLE, Model Number: ECVC8633; 39) VANTEX PI CVC 7F, 3L, 16CM BUNDLE, Model Number: ECVC6920A; 40) BIOPSY PACK, Model Number: DYNDH1135B; 41) PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; 42) VANTEX 7F 16CM 3L PI CVC BUNDLE, Model Number: ECVC7485; 43) ULTRA SOUND TRAY, Model Number: CVI190; 44) BASIC BIOPSY TRAY, Model Number: SPEC0051; 45) MULTIMED 7F 20CM 3L CVC BUNDLE, Model Number: CMPM7203LBB; 46) TRIPLE LUMEN CVC INSERTION TRAY, Model Number: ECVC1490A; 47) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; 48) LOCAL INFILTRATION TRAY, Model Number: DYNDH1406; 49) VANTEX 7FR 20CM 3L CVC BUNDLE, Model Number: ECVC8632; 50) I & D KIT, Model Number: ID1135A; 51) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC8637; 52) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number: ECVC5080; 53) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; 54) VASCULAR ACCESS INSERTION KIT, Model Number: CVI5331; 55) VANTEX 7F 20CM 3L CVC BUNDLE PLUS, Model Number: CMPV7203LBPA; 56) VANTEX 7FR 3L 20CM BUNDLE, Model Number: ECVC6110B; 57) A LINE KIT, 20G, Model Number: ART1303; 58) DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; 59) 7FR 3L 20CM CVC INSERTION BNDL, Model Number: ECVC7830C; 60) CVC INSERTION KIT 3L-16CM, Model Number: ECVC8616; 61) VANTEX 7FR 3L 20CM CVC BUNDLE US, Model Number: ECVC8320A; 62) VANTEX 7F 20CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8385B; 63) TRIPLE LUMEN BUNDLE, Model Number: ECVC5475; 64) CVC BUNDLE KIT, Model Number: ECVC1700; 65) 3" 20G RADIAL ARTERIAL LINE KIT-ICU, Model Number: ART240C; 66) MAXIMUM PROTECTION CVC INSERTION KIT, Model Number: ECVC1950; 67) CVC TRIPLE LUMEN 7FR PI 16CM BUNDLE, Model Number: ECVC8360; 68) PLASTICS SUTURING SET, Model Number: SUT4065; 69) 3L 7F 20CM CVC INSERTION KIT, Model Number: ECVC8465; 70) ARTHROGRAM TRAY, M

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Medical device recall Priority 58
openFDA Medical device

Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Medical device recall Priority 58
openFDA Medical device

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 The Provena" Midline Catheters are intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medical device recall Priority 58
openFDA Medical device

5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medical device recall Priority 58
openFDA Medical device

CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 S1173108D4 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155031 S1173108D5 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155130 S1173108D6 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741232190 S1193108D3 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154980 S1193108D4 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155086 S1193108D5 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155185 S1193108PD PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741134135 S1274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130366 S1274108D4 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155055 S1274108D5 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155154 S1294108D PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130373 S1294108D2 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154898 S1294108D4 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155109 S1294108D5 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155208 S3173108 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130144 S3274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130403 S9274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130441 The PowerPICC Provena Catheters and PowerPICC Provena Catheter with SOLO Valve Technology are indicated for short and long term peripheral access to central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 guage or larger be used.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medical device recall Priority 58
openFDA Medical device

Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

Medical device recall Priority 58
openFDA Medical device

Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Medical device recall Priority 58
openFDA Medical device

Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Medical device recall Priority 58
openFDA Medical device

RayCare 2024A SP4. Oncology Information Systems.

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

Medical device recall Priority 58
openFDA Medical device

ARTIS icono ceiling. Model Number: 11328100.

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

Medical device recall Priority 58
openFDA Medical device

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

Medical device recall Priority 58
CPSC

Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards

X-Force Flex vacuum cleaner (red, black and silver) that has the recalled lithium-ion battery in the handle

This recall involves cordless vacuum cleaners with a recalled lithium-ion battery that is housed in the handle of the device. The vacuum is sold in red, black and silver. There are two models, X-Force Flex 14.60 Animal, model number RH99A2U1 and X-Force Flex 15.60 Animal, model number RH99F2U1. The Versatile X-Force's lithium-ion battery model number is ZR0097U2 with a date code that begins with either 23 or 24. The...

Consumer product recall Priority 54
CPSC

Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries; Sold on Amazon by JSNJ_Tech Store

Recalled Junpower CR2032 batteries (Packaging model 2023-V3)

This recall involves Junpower CR2032 Batteries (20 pieces) in specific packaging (Packaging model 2023-V3). The product is packaged in a white box labeled "JUNPOWER Household Batteries," with four packs inside, each pack contains five batteries.

Consumer product recall Priority 54
CPSC

Projecting LED Finger Light Toys Recalled Due to Risk of Serious Injury Death from Battery Ingestion; Violate Mandatory Standard for Toys; Sold on Amazon by POPOOO

Recalled POPOOO LED Jungle Safari Projecting Finger Lights

This recall involves POPOOO Jungle Safari LED Finger Lights. They were sold in sets of 24 multi-colored lights with white fingertip covers. Each finger light has three internal button cell batteries that power projections of the jungle safari characters when activated. "POPOOO" and "LED FINGER LIGHTS" are printed on the product's blue packaging.

Consumer product recall Priority 54
CPSC

Topyond Pool Drain Ports with Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violate Virginia Graeme Baker Pool & Spa Safety Act; Sold by Jialyduu

Recalled Topyond Pool Drain Port (Top View)

This recall involves Topyond white pool drain port with cover, sold as a Port Replacement Drainer for swimming pools. The plastic unit comes in a cardboard box with "SP-2850V" printed in bold, and a label which reads: "X004F4YG5X, Topyond Pool Drain Port Repl. MADE IN CHINA". Included in the box are stainless steel screws. The Topyond Pool Drain Port measures 9.1 inches by 6.7 inches and has a 2.3-inch opening for c...

Consumer product recall Priority 54
CPSC

Conair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard

Triple Bristle Grill Cleaning Brush

This recall involves Cuisinart metal wire bristle grill brushes. The brushes have black plastic, stainless steel, and wood handles. The following model numbers are included in this recall and can be found on the product packaging: CCB-100, CCB-4125, CCB-5014, CCB-6450, CCB-8012, CCB-4114, CCB-W2, and CSBS-777. The word "Cuisinart" is stamped on the brush handle. Some of the recalled brushes were also sold as part of...

Consumer product recall Priority 54
CPSC

Cooper Lighting Recalls Metalux Optimized High Bay LED Light Fixtures Due to Fire Hazard

Recalled Metalux Optimized High Bay (OHB) LED Light Fixture

This recall involves Metalux Optimized High Bay (OHB) LED light fixtures used indoors in commercial structures with high ceilings such as warehouses and commercial bays. The fixtures are painted white metal and measure between 2 feet and 4 feet in length and between 1 foot and 1.5 feet in width, with a plastic diffuser lens cover. The catalog number and date code are printed on the product label inside of the fixtur...

Consumer product recall Priority 54
CPSC

Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards

Recalled Roman Candles 8 Shot 3-Pack Firework Devices

This recall involves the Roman Candles 8 Shot firework devices, Model Number RCLR-W8012. The recalled products were sold in colors red, white and blue and weigh approximately 2 pounds. The firework measures 21 inches by 1 inch by 3.5 inches. The product packaging has a red, white and blue label that has the word "Hometown" written on it. The label has images of American flags in the background.

Consumer product recall Priority 54
CPSC

Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards

Recalled Unity 7 Shot 200 Gram Aerial Cake Firework Devices

This recall involves the Unity 7 Shot 200 Gram Aerial Cake firework devices, model MEF6096. The recalled products were sold in colors red, white and blue and weigh approximately one-third of a pound. The size measures 2.9 inches by 2.9 inches by 3.9 inches. The product has a red, white and blue label that has the word "Unity" written on it. The label has images of American flags in the background. The date codes bet...

Consumer product recall Priority 54
CPSC

AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows and Infant Support Cushions; Sold on Amazon by Pretty-Life

Recalled AMASKY Nursing Pillow – in white with crocodile pattern

This recall involves AMASKY Nursing Pillows. The nursing pillows are C-shaped and sold in white with a crocodile pattern as well as other various colors and patterns. "Brand: AMASKY," "Model No.: BXP99/BXP93/BXP94/BXP96/BXP97" and "Batch Number: 202506001" are printed on a label attached to the pillow.

Consumer product recall Priority 54
CPSC

Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging

Recalled CVS Health Medicated Hemorrhoidal Wipes

This recall involves CVS Health Medicated Hemorrhoidal Wipes. The pain-relieving wipes were sold in boxes of 20 individually wrapped packets of flushable wipes. The CVS Health logo, a yellow heart, "Rapid Pain Relief" and "Medicated Hemorrhoidal Wipes" is printed on the front of the packet and the box.

Consumer product recall Priority 54
CPSC

Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard

Recalled Gigglescape Under the Sea Popping Toy – Side View

This recall involves Gigglescape Under the Sea Popping Toys. The recalled toys have a clear plastic dome attached to a blue plastic base shaped like a whale. There are colored balls inside the dome, which pop up when the child pushes an external plunger at the top of the dome. The recalled popping toys have the Gigglescape brand printed on the front of the package and imprinted on the bottom of the blue plastic base.

Consumer product recall Priority 54
CPSC

Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory Standard for Infant Sleep Products

Recalled VEVOR Baby Lounger – Snow Deer

This recall involves VEVOR baby loungers. The recalled baby loungers are made of a foam sleeping pad and padded bumpers with a cloth cover and have a ribbon at one end. They were sold in the following colors and prints: snow deer, good night, forest friends (oval), forest friends (backpack), and green.?"VEVOR" is printed on an attached tag on the outside of the baby lounger's cover.

Consumer product recall Priority 54
CISA KEV

Adobe ColdFusion Path Traversal Vulnerability

Adobe ColdFusion contains a path traversal vulnerability that could lead to arbitrary code execution in the context of the current user.

Known exploited vulnerability Priority 53
openFDA Medical device

INZONE DETACHMENT SYSTEM, REF: M00345100950

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

Medical device recall Priority 51
openFDA Medical device

Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Medical device recall Priority 51
openFDA Medical device

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction d...

Medical device recall Priority 51
openFDA Food

Dried Herring Fish 7 oz.

Improperly eviscerated which may result in Clostridium botulinum contamination

Food recall Priority 51
openFDA Food

6/11oz No Salt Sunflower Seeds

The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.

Food recall Priority 51
openFDA Food

Joy Rose Lassi 16 oz.

Product not adequately pasteurized

Food recall Priority 51
openFDA Food

25# Sunflower Seeds C/S

The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.

Food recall Priority 51
openFDA Food

Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Innovations***1845 Colonial Parkway Norwalk, IA 50211***"

Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich

Food recall Priority 51
openFDA Medical device

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

Medical device recall Priority 51
openFDA Medical device

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medical device recall Priority 51
openFDA Medical device

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medical device recall Priority 51
openFDA Medical device

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medical device recall Priority 51
openFDA Medical device

Octopus Evolution AS Tissue Stabilizer, Model TS2500

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

Medical device recall Priority 51
openFDA Medical device

Octopus 4 Tissue Stabilizer, Model 29400

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

Medical device recall Priority 51