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 10301–10320 of 38,428 recalls
Recalled Item: SKYN ORIGINAL NON LATEX CONDOM 12CT
The Issue: Affected product was not appropriately stored in temperature-controlled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ
The Issue: Affected product was not appropriately stored in temperature-controlled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) CVS Health Sterile Surgical Pads
The Issue: The product falls apart during handling after removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD
The Issue: There is the potential for reduced shock energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD
The Issue: There is the potential for reduced shock energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt Implantable Cardioverter Defibrillators with Cardiac...
The Issue: There is the potential for reduced shock energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization...
The Issue: There is the potential for reduced shock energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD
The Issue: There is the potential for reduced shock energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt Implantable Cardioverter Defibrillators with Cardiac...
The Issue: There is the potential for reduced shock energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit
The Issue: Due to preventative maintenance (PM) not being performed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABACUS TPN (Total Parenteral Nutrition) Calculation software
The Issue: There is a potential risk of medication error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revogene
The Issue: When a run is aborted, the cooling period
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CereLink ICP Monitor
The Issue: Integra has received complaints associated with ICP readings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Cholesterol- For the quantitative in vitro determination of Cholesterol
The Issue: Product fails to meet the performance claims quoted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaC UNO H [120V
The Issue: Internal ethemet cables are missing one or both
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaC UNO H [120V
The Issue: Internal ethemet cables are missing one or both
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: etouchus
The Issue: Device was marketed without FDA 510(k) clearance or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Description/Part: Simplify Disc Size 1
The Issue: Cervical artificial disc Unique Device Identifier (UDI) barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for
The Issue: BD Intraosseous Needle Kits may exhibit: 1) Increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene CDF Nucleic Acid Test
The Issue: There is a potential for false negative results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.