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 1621–1640 of 38,428 recalls
Recalled Item: STA Satellite. Product Code: All . All software versions. The
The Issue: for contamination of STA-LIQUID ANTI-Xa by Stago
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid
The Issue: for contamination of STA-LIQUID ANTI-Xa by Stago
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA -
The Issue: for contamination of STA-LIQUID ANTI-Xa by Stago
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra IABP Catheter Kit Product Name: Ultra IABP
The Issue: Device contains indications for use and device compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID
The Issue: Their is a potential that the reamer may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO SURGICAL Product Name: FA S Altivate Reverse
The Issue: Their is a potential that the reamer may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID
The Issue: Their is a potential that the reamer may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID
The Issue: Their is a potential that the reamer may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control
The Issue: Foley catheter trays have incorrect inserts, user may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control
The Issue: Foley catheter trays have incorrect inserts, user may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray
The Issue: Foley catheter trays have incorrect inserts, user may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant
The Issue: Measles IgM Test Kit lacks premarket approval or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Pack
The Issue: Surgical drape packs may have open seals, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IPC Powerease System UDI-DI: 00613994448705 00643169406834. The IPC
The Issue: Due to out of the box wobble of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle 3 with TumorLOC
The Issue: Due to software issue, Radiation Therapy Planning system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOPS Inserter
The Issue: for missing pins at tip of inserter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Medical Video Processor
The Issue: During endoscopic procedures using a combination of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dynex Agility Sample Tips
The Issue: The internal label affixed to the sample tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chromophare Surgical Light System
The Issue: Surgical lights have stress lines forming on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prosthesis Head B
The Issue: Inconsistent size terminology and color coding used on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.