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 30081–30100 of 38,428 recalls
Recalled Item: Syngo.via and Syngo.x
The Issue: measurements drawn on the 2nd and subsequent images
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LapSac Surgical Tissue Pouch. The current intended use for the
The Issue: Includes Information not stated in the intended use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson
The Issue: The intake port may be blocked which can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Optigun Ratchet is a hand-held cement gun for use
The Issue: The pin which maintains the knob button, may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilite Analyser
The Issue: risk of the Optilite lid/cover falling suddenly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SEDASYS Computer-Assisted Personalized Sedation System
The Issue: Ethicon has found that disinfecting methods not specified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StoneLight 30 Laser System (NS3000). For use in surgical procedures
The Issue: During internal testing a situation was discovered where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The spare component Anti-HBs Cutoff Calibrator
The Issue: The spare component Anti-HBs Cutoff Calibrator, Catalog number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws
The Issue: Certain lots of the 3.7mm Cannulated Locking Screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC unit model 8015
The Issue: An issue with the cancel functionality used during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extentrac Elite User Manual DCN: 14-001 (Powered decompression table
The Issue: Item is marketed for use in patients weighing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extentrac Elite product brochure DCN: 13-001
The Issue: Item is marketed for use in patients weighing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated
The Issue: affected parts and lots of the Cannulated Drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReUnion TSA Shoulder System
The Issue: A package labeled as Part #5901-S-4818, Lot MAC7C14,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm
The Issue: breach in sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN
The Issue: There is a possibility that the thumb button
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOTECH Endoscope Cleaner and Reprocessing System 220-230V
The Issue: Advanced Sterilization Products (ASP) is recalling the EVOTECH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alkaline Wash
The Issue: The product is leaking from the cap and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOTECH Endoscope Cleaner and Reprocessing System 208V
The Issue: Advanced Sterilization Products (ASP) is recalling the EVOTECH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP
The Issue: Discrepancies for Siemens BCS / BCS XP with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.