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 5001–5020 of 38,428 recalls
Recalled Item: Bard Medical SureStep Foley Tray System
The Issue: Some of the devices may function incorrectly resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Tempus LS-Manual Defibrillator
The Issue: Simultaneous ECG measurements with multiple devices, including a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Multitest 6-Color TBNK CE-IVD
The Issue: Multitest with compromised raw material used to assess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centrella Max - The Centrella Smart+ Bed is intended for
The Issue: There is a potential for the top cover
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec HeartMate System Monitor
The Issue: System monitor screen may display atypical behavior: Overlapping
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return
The Issue: Reports of patient burns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro
The Issue: The results generated by the VITROS Immunodiagnostic Products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider
The Issue: for an incomplete seal on the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip
The Issue: for an incomplete seal on the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ReNewal Reprocessed Covidien LigaSure Impact
The Issue: for an incomplete seal on the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis
The Issue: for an incomplete seal on the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum
The Issue: Due to a manufacturing defect from the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum 360/A+ spare batteries. Item Number: SUB0000864.
The Issue: Due to a manufacturing defect from the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replacement Battery List Number SUB0000864
The Issue: Due to a manufacturing defect from the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORI Starter Kit
The Issue: CORI Surgical System with Real Intelligence Software exhibits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access
The Issue: Defect in the external sterile packaging (pouch) leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated
The Issue: Defect in the external sterile packaging (pouch) leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining
The Issue: Defect in the external sterile packaging (pouch) leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to
The Issue: Assays may produce false negative results due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Contract Systems Spine Pack convenience kit
The Issue: Product released with insufficient aeration time impacting the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.