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 24181–24200 of 38,428 recalls
Recalled Item: Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
The Issue: The Doppler velocity measurement on the Sonimage HS1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument...
The Issue: Over-tensioning of the band resulting in damage to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microalbumin Reagent
The Issue: Beckman Coulter has confirmed that MA Reagent Lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brennen Skin Graft Mesher. Surgical instrument designed to expand skin
The Issue: Sterilization validation failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 600 Coulter Cellular Analysis System
The Issue: There is a possibility of a data acquisition
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 800 Coulter Cellular Analysis System
The Issue: There is a possibility of a data acquisition
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips V60 Ventilators
The Issue: Over time, low-frequency vibrations can cause the pins
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397
The Issue: Greatbatch Medical has voluntarily initiated a Recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent
The Issue: May result in elevated platelet backgrounds during routine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical
The Issue: The exam light may have a tolerance issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PE CONNECTOR 5 IN 1 20/BX
The Issue: Labeling: The expiration date is not stated on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Silicone Flat Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Silicone Flat Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt PVC Round Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Silicone Flat Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Silicone Round Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Silicone Round Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Silicone Round Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Hemaduct Silicone Round Drain
The Issue: Product's seal possibly compromised, potentially compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.