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 32701–32720 of 38,428 recalls
Recalled Item: ARIATELE TELEMETRY TRANSMITTER
The Issue: The transmitter display and the Telemetry Central Station
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EN MENTOR Round High Profile Single Use Saline Breast Implant
The Issue: The device labeling is stamped with 330cc and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPR Shield With One Way Valve and Barrier Filter
The Issue: "THIS SIDE UP" is on the wrong side
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL
The Issue: There was an error in manufacturing which resulted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DX-D 600 - DXD Imaging Package Product Usage:Is indicated for
The Issue: Some customers reported that while using the DX-D600
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INSIGHT Dental Film
The Issue: The Indicator Dot on the film packet's outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra-speed Dental Film
The Issue: The Indicator Dot on the film packet's outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard 360 Femoral Boss Reamer
The Issue: The Vanguard 360 Femoral Boss Reamers were manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray
The Issue: The firm discovered that the current Personal Tibial/General
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray
The Issue: The firm discovered that the current Personal Tibial/General
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor
The Issue: The blood pressure (BP) circuit occasionally fails to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch)
The Issue: Zimmer is initiating a voluntary recall of 20
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument
The Issue: Risk of incorrect results from samples prepared with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InSite HER-2 Detection Kit
The Issue: Product was distributed without 510(k) approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH
The Issue: There is a possibility the handle of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
The Issue: A screw set was returned from the field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IP5 Information Portal The Expression Information Portal (Model IP5)
The Issue: The wireless function of the IP5 radio could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHAROS Excimer Laser
The Issue: RA Medical Systems is recalling the PHAROS EX-308
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo Imaging XS
The Issue: Siemens has become aware of the potential malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The
The Issue: STERIS has identified that deformation of the washers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.