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 34901–34920 of 38,428 recalls
Recalled Item: Zimmer Title 2 Bone Screw Remover Instrument
The Issue: Possibility of the weld to the quick-connect breaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens
The Issue: Reports relating to Biomet 3i's BellaTek Zirconia Dental
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Mammo is a multi-modality
The Issue: There is a potential safety issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating
The Issue: Edwards Lifesciences is recalling two lots of Duraflo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610)
The Issue: Test results from these lots may produce a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating
The Issue: Edwards Lifesciences is recalling two lots of Duraflo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Titanium Prosthesis
The Issue: One lot of the product was assembled using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Epilor Syringe BD Franklin Lakes
The Issue: BD has received several reports indicating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205....
The Issue: The inner diameter of the Sleeve shaft is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anchored Lateral Retractable Drill
The Issue: The outer diameter of the Drill shaft is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07
The Issue: The inner diameter of the Sleeve shaft is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectre Wireless Footswitch/Handswitch system Model 98/99
The Issue: TransAmerican Medical Imaging is recalling certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET Spine
The Issue: Polaris Translation Screw Failures were recently reported to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgicutt fully automated incision making device for bleeding time...
The Issue: ITC has determined that the blade in their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxa Vial Adapter
The Issue: Baxter Healthcare Corporation is voluntarily recalling one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts
The Issue: No antibacterial bandages were packed in boxes labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.