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 6201–6220 of 38,428 recalls
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Laparoscopic Instruments
The Issue: Insulation on the tube did not extend fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custodiol HTK Solution
The Issue: for particles to be present in solution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Invos
The Issue: manufacturing defects to sensor cable connectors may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Invos
The Issue: manufacturing defects to sensor cable connectors may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
The Issue: Facility Critical Temperature Excursions on 08-JAN 2024 in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
The Issue: Facility Critical Temperature Excursions on 08-JAN 2024 in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
The Issue: Facility Critical Temperature Excursions on 08-JAN 2024 in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set
The Issue: Facility Critical Temperature Excursions on 08-JAN 2024 in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
The Issue: Facility Critical Temperature Excursions on 08-JAN 2024 in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DISP.HASSON TROCAR 10/110MM
The Issue: The sterile blister packaging may be damaged, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DISP.TROCAR W.DILATING PIN 12/110MM
The Issue: The sterile blister packaging may be damaged, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DISP.TROCAR W.DILATING PIN 12/110MM
The Issue: The sterile blister packaging may be damaged, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DISP.TROCAR W. DILATING PIN 10/110MM
The Issue: The sterile blister packaging may be damaged, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.