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 19901–19920 of 38,428 recalls
Recalled Item: CHS Custom Convenience Kit-PAD
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHS Custom Convenience Kit-SURGICAL GOWN
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP)...
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product...
The Issue: Convenience kits were sealed in immediate Tyvek pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVS Aria Cage
The Issue: The anterior and posterior markers on the cage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK(R) 2 AST-P655
The Issue: Routine internal review of Device History Records identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK(R) 2 AST-P640
The Issue: Routine internal review of Device History Records identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IsoFlex LAL Support Surface
The Issue: Certain 2860 IsoFlex LAL support surfaces were assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML
The Issue: Products have intermittently failed performance testing during stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: remel THIOGLYCOLLATE MEDIUM
The Issue: Products have intermittently failed performance testing during stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML
The Issue: Products have intermittently failed performance testing during stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For
The Issue: A deterioration of performance was identified with influenza
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific AutoHDL/LDL Cholesterol Calibrator
The Issue: Vials of the autoHDL/LDL Calibrator were shipped without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This...
The Issue: Some of the Disposable Smooth Interior Tubing may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
The Issue: The Distal Flush Tool (DFT) accessories that were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.