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 26581–26600 of 38,428 recalls
Recalled Item: OEC 9800
The Issue: A firmware issue in the supplied LCD workstation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen
The Issue: Device can fail during operation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS Sterile Transparent Film and all the RENASYS Dressing kits
The Issue: Sterility seal integrity failures on the Renasys Sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FPS 35mm x 3.5 mm non-locking screw
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMR allen wrench 5 mm
The Issue: Product found to be dimensionally non-conforming (slightly over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Large QWIX Compression screw
The Issue: Labeling on the Qwix Screw product states that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Brain 3.0.0 Usage: The device is intended for the
The Issue: Communication errors between ROSANNA BRAIN software, MARIO software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterling Diagnostics
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterling Diagnostics
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterling Diagnostics
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC...
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterling Diagnostics
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterling Diagnostics
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterling Diagnostics
The Issue: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BLUE IMPERVIOUS GOWN WITH THUMBHOOKS
The Issue: Blue Impervious Gown with thumbhooks, X-large. All lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry XPT
The Issue: Siemens identified an issue with the ratio equation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 16 Power
The Issue: After upgrading to 3.6.7 software version via FCO72800643,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography
The Issue: After upgrading to 3.6.7 software version via FCO72800643,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.