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 37461–37480 of 38,428 recalls
Recalled Item: Merge HEMO software.
The Issue: The International Normalized Ratio (INR) value displayed in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix...
The Issue: Ethicon and Omrix Biopharmaceuticals have received reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KY LIQUIBEADS Vaginal Moisturizer
The Issue: Johnson & Johnson Healthcare Products (JJHP) is voluntarily
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3mL 9NC Coagulation Sodium Citrate 3.2%
The Issue: Part of the lot received a lower concentration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical...
The Issue: Some clip applier units may be inadequate to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian brand Varian ARIA Oncology Information System
The Issue: A software anomaly has been identified with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bella Blanket Protective Coverlet
The Issue: Imaging artifact can occur on mammogram result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Brilliance 6
The Issue: Philips Healthcare was notified that several of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drager PT 4000 Phototherapy System
The Issue: A routine internal quality check found that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM...
The Issue: The MXR-35 X-ray Generator's labeling did not include
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACS 7-color Setup beads BD Biosciences
The Issue: Incorrect version of the CD was included with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Foley procedural trays packaged in breather bags. The product
The Issue: Incomplete seal on sterile packages of product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module model 8100. Subsequent product code: FPA The
The Issue: The recall was initiated because Carefusion identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chorus Mobile Patient Lifter
The Issue: ArjoHuntleigh has received a limited number of customer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sara Plus Mobile Patient Lifter
The Issue: ArjoHuntleigh has received a limited number of customer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Encore Mobile Patient Lifter
The Issue: ArjoHuntleigh has received a limited number of customer
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: VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product
The Issue: Ortho Clinical Diagnostics revised the VITROS Chemistry Products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD Cyclesure Biological Indicator (BI)
The Issue: Advanced Sterilization Products (ASP) is recalling certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mar Cor Purification CWP Reverse Osmosis System. Models 101
The Issue: There exists a potential situation with the crimp
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.