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Medical device recalls

Medical device recalls from FDA, newest first.
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8 recalls

GORE VIABIL Short Wire Biliary Endoprosthesis

The GORE VIABIL biliary endoprosthesis may be mislabeled, with a 10 mm x 7 cm device labeled as a 10 mm x 10 cm device.

Moderate risk, FDA, Labeling error

Roche Navify Digital Pathology Software

Navify Digital Pathology software has an image/metadata discrepancy with the Viewer window.

Moderate risk, FDA, Device defect

BOBBY Balloon Guide Catheter

The BOBBY Balloon Guide Catheter has an increased rate of balloon pinhole defects.

Moderate risk, FDA, Device defect

5 recalls

Contego Medical Neuroguard IEP Carotid Stent and Balloon System

The Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System may fail to open its integrated filter.

Moderate risk, FDA, Device defect

TISSIUM COAPTIUM Connect Peripheral Nerve Repair Devices

Currently labeled shelf life of 36 months is not substantiated by real-time data.

Moderate risk, FDA, Labeling error

Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis

The Blom-Singer Classic Indwelling Voice Prosthesis has incorrect labeling.

Moderate risk, FDA, Labeling error

Instrumentation Laboratory GEM Premier 7000 and GEM Premier 5000 Blood Analyzers

The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 and GEM Premier 5000 PAK lots did not meet established manufacturing specifications.

Moderate risk, FDA, Device defect

U2 Total Knee System Femoral Offset Bushings

Femoral offset bushings have incorrect engraved numbering that could cause incorrect implant orientation.

Moderate risk, FDA, Device defect

8 recalls

Medline Hudson RCI Heated Neonatal Breathing Circuits

Neonatal and infant heated wire breathing circuits may experience sporadic failure.

Moderate risk, FDA, Device defect

Siemens Healthcare Diagnostics Atellica CH Urine Albumin

Atellica CH Urine Albumin tests may cause falsely depressed urea nitrogen and hemoglobin A1c results.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan LabPro Panel Update Software

MicroScan LabPro V5.03 Panel Update 11 has incorrect algorithms that may affect antimicrobial susceptibility test results.

Moderate risk, FDA, Software defect

Aniara Diagnostica 5-PLASMA Bivalirudin Kits, Calibrators and Controls

The 5-Plasma Bivalirudin AMR Verification Kit has stability issues that degrade measurable bivalirudin.

Moderate risk, FDA, Quality testing problem

Philips Allura and Azurion X-Ray Systems

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Moderate risk, FDA, Device defect

HardyDisk AST Cefiderocol 30µg (FDC30)

Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.

Moderate risk, FDA, Device defect

United Orthopedic U2 and USTAR II Knee Trial and Instrument Sets

Knee femur prosthesis trials and adaptors may not assemble properly due to an incomplete process of the component screw.

Moderate risk, FDA, Device defect

Boston Scientific Infinion CX Lead Kit

The INFINION CX lead kit may have stress at the anchor site, causing high impedance or lead fractures.

High risk, FDA, Device defect

7 recalls

GE Healthcare Portrait Core Services Software

GE Healthcare Portrait Core Services SW V 1.2.0 patient monitoring system has a software vulnerability that may allow unauthorized access.

Moderate risk, FDA, Software defect

FilmArray NGDS Warrior Panel

The FilmArray NGDS Warrior Panel has mismatches between the outbreak strain and the reference strain used in its development.

Moderate risk, FDA, Device defect

GE Healthcare MAC VU360 Electrocardiographs

After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity.

Moderate risk, FDA, Software defect

Merge OrthoPACS and PACS

Merge PACS may show thumbnails from a previous patient study while another is open.

Moderate risk, FDA, Device defect

Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls have out-of-specification sodium azide concentration, causing low health risk.

Low risk, FDA, Quality testing problem

Syva Emit Disopyramide Assay Enzyme Immunoassay

The Syva Emit Disopyramide Assay has an out-of-specification sodium azide concentration, which can cause mild skin or eye irritation.

Low risk, FDA, Quality testing problem

Happiest Baby Pre-Loved SNOO Smart Sleeper

The pre-loved SNOO Smart Sleeper failed to meet quality standards before distribution.

Moderate risk, FDA, Device defect

7 recalls

Maquet Flow Anesthesia Machines

Events observed where anesthetic agent was not delivered when the vaporizer was activated.

Moderate risk, FDA, Device defect

Zimmer Biomet Intramedullary Bone Saw Blade Assembly

The Intramedullary Bone Saw Blade Assembly may have damaged sterile barrier packaging due to an exposed saw blade.

Moderate risk, FDA, Sterility problem

Stryker Ahto Tube Sets and Suction/Irrigator Packaging

Stryker tube sets can leak from the handpiece during use.

Moderate risk, FDA, Device defect

Medical Action Industries Dialysis Change Tray Clear Sequence

The Dialysis Change Tray Clear Sequence has an improper seal that may cause doming or tearing of the silicone seal.

Moderate risk, FDA, Device defect

OXOS Medical MC2 Portable X-Ray System

The MC2 Portable X-Ray System has a defective circuit board that overheats.

Moderate risk, FDA, Device defect

Innovasis Vector Pedicle Screw System Anti-Torque

The anti-torque instrument may have an undersized condition that could prevent it from engaging with the screw, leading to surgical delay.

Moderate risk, FDA, Device defect

Nuclein DASH Rapid PCR Instrument

Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Moderate risk, FDA, Software defect

9 recalls

Halyard Cardiac Catheterization and Angiography Kits

Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

High risk, FDA, Foreign object

Munevo DRIVE and Munevo DRIVE R-Net Powered Wheelchair Hands-Free Control Application

A software issue may cause the wheelchair's driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.

Moderate risk, FDA, Software defect

THERANICA BIOELECTRONICS Nerivio Infinity

Nerivio Infinity has a potential for a thermal-runway event during charging, resulting in smoke and odor.

Moderate risk, FDA, Device defect

Copan WASPLab Automated Culture Plate Incubators and Imagers

WASPLab has a software issue that may prevent users from overwriting results.

Moderate risk, FDA, Software defect

Boston Scientific Radial Jaw 4 Biopsy Forceps

Radial Jaw 4 Standard Capacity Biopsy Forceps may have a breach in the sterile barrier of their packaging.

Moderate risk, FDA, Sterility problem

FORWARD Oral Airway Kit and Kingfisher Compact Individual First Aid Kit

The FORWARD Oral Airway Kit may have an occluded or partially occluded Guedel Airway tip.

Moderate risk, FDA, Device defect

Quantum Rehab Power Wheelchairs

Quantum Rehab powered wheelchairs may show reminder pop-ups while in use, which can cause an unexpected park brake stop and lead to a fall or injury.

Moderate risk, FDA, Device defect

Charger for the Therabody Theragun, G4 PRO Massage Device

The charger for the Theragun G4 PRO may overheat, posing a fire risk.

Moderate risk, FDA, Device defect

Normand Info REMISOL Advance Data Manager

REMISOL Advance Data Manager software may replace final combo test results with sub-results, causing incorrect reporting.

Moderate risk, FDA, Software defect

3 recalls

Bard Access Systems BD Needle Kit for Powered Driver

BD Needle Kit for Powered Driver may have difficulty removing the obturator, potentially delaying therapy and causing serious injury or death.

High risk, FDA, Device defect

Terex Utilities Power Over Fiber Base Module

The Power Over Fiber Base Module is not certified and is improperly labeled.

Moderate risk, FDA, Unapproved product

Medical Action Industries Medline Angiographic Manifold Packs

Cardiovascular procedure kits contain manifolds that may have particulate within the fluid path, which could become lodged in blood vessels.

High risk, FDA, Foreign object

2 recalls

Stryker Hoffmann II Connecting Rod Micro

Stryker Hoffmann II Connecting Rod Micro may crack following cleaning and sterilization.

Moderate risk, FDA, Device defect

Instrumentation Laboratory GEM Premier 5000 and GEM Premier 7000 Blood Analyzers

GEM Premier 5000 and 7000 systems with BCR wands may assign results to wrong patient.

Moderate risk, FDA, Device defect

2 recalls

SeaSpine OsteoBallast and Ballast Bone Grafts

The products were filled with approximately 4.5 cc DBM instead of approximately 7.5 cc DBM.

Moderate risk, FDA, Device defect

ResMed Astral 100 and 150 Ventilators

The Resmed Astral ventilator system can fail due to electrolyte leakage, interrupting ventilation therapy.

High risk, FDA, Device defect

3 recalls

Philips CT Scanners

The CT scan may not trigger automatically after Bolus Tracking, causing inadequate diagnosis and potential rescan.

Moderate risk, FDA, Device defect

AMS Aligned Medical Solutions Medical Convenience Kits

Medical convenience kits contain Lidocaine HCl injection that may be affected by supplier quality issues.

Moderate risk, FDA, Packaging defect

Medtronic EOPA Arterial Cannulas

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass.

Moderate risk, FDA, Device defect

4 recalls

Argon Medical Devices L-Cath Catheters

L-Cath PICC S/L Peripherally Inserted Central Catheter may leak or crack at the hub, causing blood loss and infection.

Moderate risk, FDA, Device defect