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 12881–12900 of 38,428 recalls
Recalled Item: AquaBplus and AquaBplus B2 Water Purification System - Product Usage:
The Issue: AquaBplus HF module on the AquaBplus 2500 osmosis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dental pins - TMS LINK PLUS Self-Threading Pins - Product
The Issue: The incorrect dental pins were packaged and subsequently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIGENE Processor SP - Product Usage: intended for processing and
The Issue: Salmonella Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #:
The Issue: Discrepancy in labeling between the adult CBC reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Enterprise Viewer
The Issue: Change Healthcare has identified an intermittent software defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinity Biotech Captia Measles IgM Kit
The Issue: Positive Control may run high out of its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology
The Issue: The shelf box identifies a small device actually
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology
The Issue: The shelf box identifies a small device actually
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Martin-Lewis Agar
The Issue: Products show heavy growth of C. albicans after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use
The Issue: Products show heavy growth of C. albicans after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal
The Issue: Incorrect labeling, Catheter did not have the required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VAPORIZER VICKS 1.5GAL Item Number: 2354942
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.