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 27061–27080 of 38,428 recalls
Recalled Item: TI Single Vector Distractor Body with Right Foot/30mm
The Issue: DePuy Synthes is voluntarily initiating a recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TI Single Vector Distractor Body with Left Foot/30mm
The Issue: DePuy Synthes is voluntarily initiating a recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeVilbiss Model 7305P-D Powered Suction Unit
The Issue: A small percentage of units of 7305 Series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
The Issue: Presence of leaks near top of the PrismaSate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EV3 EverFiex" Self-expanding Peripheral Stent System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiesse (+) Lidocaine
The Issue: Complaints reported of Radiesse (+) unable to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
The Issue: Product did not meet specifications for Zinc Acetate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-wire
The Issue: The affected K-wires do not meet specification requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP
The Issue: Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Kalare DREX-KL80 X-ray generator
The Issue: It was discovered that the generator of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Ultimax DREX-ULT80 X-ray generator
The Issue: It was discovered that the generator of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conical portio adapter (acorn) small & large are used for
The Issue: The distal end of the Conical portio adapter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009
The Issue: A 10 Gauge needle, 9cm long was shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number:...
The Issue: The incorrect sized product, InterActive Implant Open-Tray Transfer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235 and Proteus ONE proton therapy systems
The Issue: Recall is being initiated to address on-site software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor
The Issue: US Endoscopy is conducting a voluntary product recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.)
The Issue: A version of the dual dispersive electrodes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.)
The Issue: A version of the dual dispersive electrodes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.)
The Issue: A version of the dual dispersive electrodes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult Dual Dispersive Electrodes (for patients >15 kg.)
The Issue: A version of the dual dispersive electrodes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.