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 33461–33480 of 38,428 recalls
Recalled Item: VITROS 5
The Issue: for biased results when a Multiple Window
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in
The Issue: Software anomaly: potential for delay in the reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: for biased results when a Multiple Window
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System
The Issue: for biased results when a Multiple Window
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems VitD Total 100 test
The Issue: Samples containing fluorescein may show interference with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems VitD 500 test
The Issue: Samples containing fluorescein may show interference with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems TSH3 Ultra
The Issue: Samples containing fluorescein may show interference with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS
The Issue: Samples containing fluorescein may show interference with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems TSH3 Ultra Ready Pack
The Issue: Samples containing fluorescein may show interference with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625
The Issue: Samples containing fluorescein may show interference with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems VitD 100 test
The Issue: Samples containing fluorescein may show interference with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Bicarbonate Concentrate
The Issue: Naturalyte Liquid Bicarbonate maybe contaminated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to
The Issue: Cochlear America is recalling Cochlear Baha Soft Tissue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When the E-NMT-01 module is used in conjunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3 EverCross 0.035" OTW PTA Dilatation Catheter
The Issue: Covidien is recalling 2 production lots of EverCross
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae
The Issue: for separation of dilator tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo
The Issue: for separation of dilator tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211
The Issue: Siemens investigation confirmed that a portion one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: e.cam -emission computed tomography system Used to detect or image
The Issue: There is a potential for patient finger injury
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intended for both adult and pediatric patients for taking diagnostic
The Issue: In special cases, during the start-up of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.