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 15101–15120 of 38,428 recalls
Recalled Item: ADVIA Chemistry Enzymatic Creatinine_2
The Issue: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
The Issue: Device and tray that houses the device did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Outer Sheath 4.5/5.0
The Issue: Device and tray that houses the device did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 670G
The Issue: Missing solder battery connection, which could interrupt power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 640G
The Issue: Missing solder battery connection, which could interrupt power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 630G with SmartGuard
The Issue: Missing solder battery connection, which could interrupt power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remisol Advance running Software Version 1.12 The Normand Info Remisol
The Issue: Results from repeated run for WBC (White Bloodcell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
The Issue: Incorrect labeling of dialysate concentration for hemodialysis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity
The Issue: risk that Legionella may be present in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray
The Issue: Artis systems containing a Multi Display Manager of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Monitoring Set
The Issue: The Pressure Monitoring Set and Tray may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centrella Smart+ Bed
The Issue: The Bed Exit System may fail to send
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Monitoring Tray
The Issue: The Pressure Monitoring Set and Tray may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature...
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 100% Silicone Premium Urine Meter Foley Tray
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 400mL
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature...
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.