Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 3221–3240 of 38,428 recalls
Recalled Item: X-Flow prostatectomy catheter
The Issue: A possible sterility issue was detected in Coloplast's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Cardiology Hemo software
The Issue: Software defect concerning autosave mechanism may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VerifyNow P2Y12 Platelet Reactivity Test
The Issue: Platelet Reactivity Test distributed without appropriate US-FDA market
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology Hemo software
The Issue: Software defect concerning autosave mechanism may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Cardiology Hemodynamics software
The Issue: Software defect concerning autosave mechanism may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Folysil Silicone Foley Catheters
The Issue: A possible sterility issue was detected in Coloplast's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MISHA Knee System Implant Small
The Issue: Knee implant may fracture due to a supplier-related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esteem Synergy Stomahesive Skin Barrier
The Issue: Ostomy skin barrier package contains a pre-cut wafer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheath
The Issue: If the inflow speed is too quick, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheath
The Issue: If the inflow speed is too quick, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheath
The Issue: If the inflow speed is too quick, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix
The Issue: Incorrect expiration date listed on the outer box,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoCove Putty
The Issue: Hydration issue resulting in the product being less
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheath
The Issue: If the inflow speed is too quick, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3B Medical
The Issue: The devices were inadvertently shipped after their expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231
The Issue: Elevated residues of anti-block/slip additive used in manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Intact PTH assay
The Issue: Beckman Coulter has identified that some Access PTH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMT Mini Enteral Extension Set
The Issue: The extension sets subject to this recall have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Unitek Transbond Plus Self-Etching Primer (100 unit
The Issue: Due to an increase of complaints for bracket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima XR200amx
The Issue: GE HealthCare has become aware that in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.