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 23401–23420 of 38,428 recalls
Recalled Item: Converters(R) Tiburon(R) Arthroscopy Drape
The Issue: Outer label of some units of product number/lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Converters(R) Under Buttocks Drape with Fluid Control Pouch II
The Issue: Outer label of some units of product number/lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt HV with Gentamicin
The Issue: Loss of the seal on the sterile Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt MV Bone Cement 40GM
The Issue: Loss of the seal on the sterile Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt MV with Gentamicin
The Issue: Loss of the seal on the sterile Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt HV Bone Cement 40GM
The Issue: Loss of the seal on the sterile Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectra-System/Legacy Guided Surgery Handle Kit
The Issue: The inside diameter of the 2.3mm small drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coulter HmX CP and Coulter HmX AL Analyzers The purpose
The Issue: Beckman Coulter has determined that additional clarification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coulter LH 750
The Issue: Beckman Coulter has determined that additional clarification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Burn Sheet
The Issue: Burn Sheet has possibility of being shredded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere iScreen Dx Urine Drug Screen Card
The Issue: The kit box label incorrectly identifies PCP (instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20
The Issue: Stryker Neurovascular has become aware that some 3-Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30
The Issue: Stryker Neurovascular has become aware that some 3-Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20
The Issue: Stryker Neurovascular has become aware that some 3-Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25
The Issue: Stryker Neurovascular has become aware that some 3-Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Truliant Tibial Trial Handle. To assist the surgeon in the
The Issue: The Truliant Tibial Trial Handle's pin may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE
The Issue: Inadequate detectability of radiopaque stripes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE
The Issue: Inadequate detectability of radiopaque stripes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Piston Syringe and Hypodermic Needle
The Issue: Insufficient documentation to support product sterility claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Piston Syringe
The Issue: Insufficient documentation to support product sterility claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.