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 34141–34160 of 38,428 recalls
Recalled Item: Stand-Alone Resuscitation Unit
The Issue: Medical device adjustment knob may be loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panda iRes¿ Infant Warmers
The Issue: Medical device adjustment knob may be loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is
The Issue: On December 13, 2012, King Systems initiated a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Latex Dental Dams labeled as Non-Latex Dental Dams
The Issue: Colt¿ne/Whaledent Inc. received a complaint about the dental
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
The Issue: Toshiba America Medical Systems, Inc. initiated this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIMVIEW NT and SIMVIEW NT with IDI: October 01
The Issue: In a very rare occurrence an intended movement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the...
The Issue: Kits incompatible with certain fluorescence microscope light sources
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Infinity Acute Care System Monitoring Solution
The Issue: After a test in which a low SpO2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: External Implant RBT
The Issue: The body length of the External Implant 40105D3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versys Build-Up Block The VerSys CRC Hip System is indicated
The Issue: Zimmer is initiating a lot specific recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT Hip System
The Issue: Zimmer is initiating a lot specific recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse
The Issue: Zimmer is initiating a lot specific recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The...
The Issue: MRx defibrillator displays a -?- for EtCO2 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Blood Set
The Issue: Occluded heparin tubing events preventing anticoagulation dosing on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PFC SIGMA Cruciate Retaining (CR)
The Issue: Knee implant femoral devices were found to have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC FX 40 instrument
The Issue: Improperly functioning component of a diagnostic medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 23ga Chow Illuminated Pick
The Issue: Faulty seals on the outer pouch of various,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 25ga Endo Illuminator
The Issue: Faulty seals on the outer pouch of various,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 23ga Mid-Field Endo Illuminator
The Issue: Faulty seals on the outer pouch of various,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.