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 9101–9120 of 38,428 recalls
Recalled Item: Surgipro Monofilament Polypropylene Sutures Product Description CP-535...
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Surgical Patties
The Issue: Integra LifeSciences identified that one lot was released
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remington MEDICAL
The Issue: The stylet is longer than specified on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lamaze Chill Teether
The Issue: Affected lots of the product are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Source Administration Set (SAS) used with the Medrad Intego PET Infusion System
The Issue: Black specks may be present on the packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ActiveAid 922
The Issue: Device manufactured with a component with affects the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular...
The Issue: Packaging sterile barrier has been compromised. Open seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSS Modular Arthrodesis Nail
The Issue: Product missing the four small locking collar bolts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ -
The Issue: Distribution without Pre-Market Clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm
The Issue: Distribution without Pre-Market Clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S...
The Issue: Distribution without Pre-Market Clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose
The Issue: Distribution without Pre-Market Clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Model 1100
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Kit
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Model 1101
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Model 1102
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Kit
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Kit
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Kit
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Kit
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.