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 21041–21060 of 38,428 recalls
Recalled Item: MicroScan Pos Combo Panel Type 43
The Issue: The drug dilution sequence for Moxifloxacin printed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drainer(R) Centesis Catheters: (a)
The Issue: The supplier of Drainer(R) centesis catheters notified Vascular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Farabeuf Clamp for 3.5mm Screws PRO
The Issue: Laser etching which indicates whether the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: remel SUPERPACK CS/ 500 SEG/FLASK
The Issue: Product may fail performance testing for S aureus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew GENESIS(R) II TIBIAL Punch
The Issue: One lot of GENESIS II 13 mm tibial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Imola (RX4900) For Professional Use for the quantitative in
The Issue: Abnormal premature termination of the software could affect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Torque Limiting Handle
The Issue: The adapter may demonstrate a degradation of function
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Clip Gun Magazines are packaged in individually sealed pouches
The Issue: The packaging sterile barrier does not comply with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONIC ACE Shears + Adaptive Tissue Technology
The Issue: The devices may have been assembled with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: Ingress of fluids into the device can affect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillator
The Issue: The MRx monitor/defibrillators could fail to charge because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS
The Issue: Joerns Healthcare has identified a potential issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProCair Mattress: (a) PROCAIR PLUS 42X80
The Issue: Joerns Healthcare has identified a potential issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONIC ACE Shears + Adaptive Tissue Technology
The Issue: The devices may have been assembled with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70
The Issue: The AXS Infinity LS Long Sheath Dilator outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Drainer Centesis Catheter
The Issue: The products listed might contain unsafe levels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centeze Centesis Catheter
The Issue: The products listed might contain unsafe levels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tearaway Introducers
The Issue: The products listed might contain unsafe levels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elite HV Introducer
The Issue: The products listed might contain unsafe levels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) TVS LPA
The Issue: The products listed might contain unsafe levels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.