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Patient-Relevant Medical Devices recalls

Devices a patient or caregiver can identify as used, worn, implanted, or supplied for their care.

Limited official informationPatient-Relevant Medical Devices

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE...

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

AffectedGSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GA...
RiskReduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and co...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV003...

Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

AffectedIntracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUME...
RiskIntraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may intr...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

A product error defect may cause incorrect bracket placement.

AffectedKL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
RiskA product error defect may cause incorrect bracket placement.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution co...

AffectedMedline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A; Medline Convenience Kits: 1) OPEN...
RiskConvenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a re...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896

A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Ins...

AffectedMiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
RiskA software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached...

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

AffectedOlympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- desi...
RiskOlympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design o...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

AffectedOmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
RiskThe current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identi...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Minia...

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

AffectedTMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M94...
RiskDue to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of t...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

VITEK 2 AST-N447 TEST KIT Product reference 424620

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

AffectedVITEK 2 AST-N447 TEST KIT Product reference 424620
RiskPotential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

AffectedA M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit; A M S, ALIGNED MEDI...
RiskKits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contam...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U...

The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.

AffectedAdapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Uppe...
RiskThe Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

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.

AffectedARTIS icono ceiling. Model Number: 11328100.
RiskPotential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some scre...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

ARTIS icono floor. Model Number: 11327700.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

AffectedARTIS icono floor. Model Number: 11327700.; ARTIS icono biplane. Model Number: 11327600.; plus 1 additional official...
RiskPotential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: 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.

AffectedBrand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 So...
RiskMay contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Iss...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Cat...

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

AffectedBrand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strip...
RiskDue to out-of-specification, or potential out-of-specification, levels of endotoxins
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number...

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

AffectedBrand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors...
RiskPotential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infectio...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen des...

AffectedBreathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-M...
RiskVentilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detec...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Cod...

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

AffectedCK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Sin...
RiskDue to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampou...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposa...

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

AffectedCovidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Cov...
RiskDue to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the prod...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

CRE Pro Wireguided 12-15mm 240cm

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

AffectedCRE Pro Wireguided 12-15mm 240cm; CRE Pro Wireguided 10-12mm 240cm; plus 10 additional official variants listed below.
RiskPotential sterile breach of the pouches in which devices are packaged.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release...

AffectedCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
RiskIn certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the ope...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release...

AffectedCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
RiskIn certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the ope...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYST...

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

AffectedDepuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes....
RiskThe external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

GC Agar Base (150mm) 10/PK R04030

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

AffectedGC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
RiskReduced or no recovery of some strains of Neisseria gonorrhoeae.
ActionNot available

Missing from associated official evidence: action, consumer scope.