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 34181–34200 of 38,428 recalls
Recalled Item: 23ga Wide Field Corona 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: BD BACTEC FX- Top Unit 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 Wide Field 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: 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier
The Issue: Faulty seals on the outer pouch of various,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stiff 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: Wide Field 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: 29ga Oshima Dual Chandelier
The Issue: Faulty seals on the outer pouch of various,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrocare SPORTS MEDICINE
The Issue: A sharp edge on the cannulated tip of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with
The Issue: Certain lots of the Aesculap Hi Line XXS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog
The Issue: The housing to the Pump's driveline connector became
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******OPTEFORM Allograft Paste 5 cc
The Issue: RTI Surgical, Inc. of Alachua, FL is recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker CMF Customized Implant Kit X-Large
The Issue: Stryker received a report from the field that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium Single Lumen Low-Profile port
The Issue: Bard Access Systems is recalling various Low Profile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone
The Issue: Bard Access Systems is recalling various Low Profile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk
The Issue: Reports that the product is not performing as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Color Cuff
The Issue: The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catheter
The Issue: Merit Medical Systems, Inc. is conducting a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Artis Q and Artis Q biplane systems Product Usage:
The Issue: There exists the possibility that during clinical operation,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed
The Issue: Intermittent noise on ECG and/or Respiration waveforms associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel
The Issue: The blue COAG button on the CUSA Excel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.