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 29241–29260 of 38,428 recalls
Recalled Item: P/N: 9735023
The Issue: Specific use conditions can increase the possibility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beef Extract Powder
The Issue: Incorrect expiration date on label. Correct expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: One Step Button
The Issue: Boston Scientific Corp. initiated a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NicoletOne Software v5.94
The Issue: When using the NicoletOne v5.94 software, after exiting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAJ-1606 Instrument Channel Adaptor
The Issue: small puncture marks in a sterile package for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk
The Issue: These custom sterile surgical kits contain the component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Software Anomaly during ADD Installation on VITROS 5,1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICroSTREP plus 1 Panel
The Issue: Beckman Coulter is recalling MICroSTREP plus 1 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICroSTREP plus 2 Panel
The Issue: Beckman Coulter is recalling MICroSTREP plus 1 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac
The Issue: Image disappeared from the cardiac ultrasound system when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carto 3 EP Navigation System. Electro physiology system which views
The Issue: Image disappeared from the cardiac ultrasound system when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for
The Issue: Incorrect tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fluorescence Imaging Procedure Kits used with the da Vinci Si
The Issue: B. Braun 2 gang 4-way stopcocks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prism Medical P-300 Portable Consumer Lift
The Issue: Drive shaft and over speed arm may simultaneously
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prism Medical C-300 Consumer Ceiling Lift
The Issue: Drive shaft and over speed arm may simultaneously
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers:...
The Issue: Certain catalog numbers and lots of Smooth Muscle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.