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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

3mensio Workstation (Vascular Fenestrated) software

User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user...

Affected3mensio Workstation (Vascular Fenestrated) software
RiskUser measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular struct...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; howev...

AffectedBoston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing...
RiskSoftware anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calcu...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appl...

Due to device not having FDA Clearance

AffectedBrand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Si...
RiskDue to device not having FDA Clearance
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Softwa...

Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording i...

AffectedEmano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflow...
RiskProblem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio wa...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402...

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, pote...

AffectedFARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Ma...
RiskBoston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated w...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

AffectedFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cat...
RiskLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter info...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

AffectedFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cat...
RiskBoston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

AffectedFlexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, RE...
RiskFlexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expi...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

AffectedHalyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
RiskIncorrect concentration of Betadine solution contained within certain AVID convenience kits.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

AffectedHalyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
RiskDefects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intraven...

ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.

AffectedHotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to th...
RiskICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets du...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G

Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC o...

AffectedMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G; MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYN...
RiskMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that includ...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on t...

AffectedMedline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC C...
RiskAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increase...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

AffectedMedline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline...
RiskMedline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which ma...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

AffectedMEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF,...
RiskThe procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose In...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insul...

AffectedMiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
RiskFor MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical informa...

Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

AffectedOlympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displayi...
RiskPotential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

AffectedOlympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
RiskPotential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflati...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-95...

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

AffectedP28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm...
RiskParagon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Due to manufacturing issues, reperfusion catheters may fractures

AffectedPenumbra System RED 68 Reperfusion Catheter REF: RED68KIT
RiskDue to manufacturing issues, reperfusion catheters may fractures
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20

Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

AffectedPipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20; Pipeline Flex Emboliza...
RiskIncorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labe...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, a...

AffectedSafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
RiskIntraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered elec...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

SeaSpine Polyaxial Head REF Number: 41-3010

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

AffectedSeaSpine Polyaxial Head REF Number: 41-3010
RiskDue to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when r...

AffectedSnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
RiskThe software controlling the wound imaging device's battery charging circuit was not designed to recognize and recove...
ActionNot available

Missing from associated official evidence: action, consumer scope.