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 35761–35780 of 38,428 recalls
Recalled Item: - Acorn Bur
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia.
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - ConMed Linvatec Spectrum II Suture Hook Crescent
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Harmonic ACE Ergonomically-Enhanced Curved Shear
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GII QuickAnchor Plus
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Glenosphere orientation guide Product Usage: The glenosphere...
The Issue: The Glenosphere Orientation Guide Instrument Used with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PadPro(R) Adult Radiotransparent Multifunction Electrodes
The Issue: ConMed was notified by the contract manufacturer that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streptex* Latex D
The Issue: The product may give weak or false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streptex* kit
The Issue: The product may give weak or false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobiletta Mira Mobile X-ray System
The Issue: Siemens issued a Field Safety Alert about the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417)
The Issue: The product has the potential for false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage:...
The Issue: Merit Medical Systems is recalling various lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421...
The Issue: Trans Warmer Infant and Transport Mattress not labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DMLC IV-ERGO Product Usage: Intended for use with rotating gantry
The Issue: It is possible for an intermittent error to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes
The Issue: BD Vacutainer Multiple Sample and Direct Draw Luer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SafetyGlide Allergy. Sterile Allergy Treatment Syringe Tray.
The Issue: There has been an increase in complaints regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers
The Issue: Applied Medical is conducting a voluntary recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.