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 2301–2320 of 38,428 recalls
Recalled Item: Tempus Pro Patient Monitor
The Issue: software issue that causes an error screen on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
The Issue: Certain lots of Atellica IM Homocysteine Calibrator and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
The Issue: Certain lots of Atellica IM Homocysteine Calibrator and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Tempus Pro Patient Monitor
The Issue: Patient Monitor software update to address issues:1)May freeze
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidewell HT Implant Twist Drill ¿1.5 x 8 mm "
The Issue: Due to packaging mix up. Package of finished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges
The Issue: Product was incorrectly assigned GEN 88 instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plus Initial Drill
The Issue: The referred batch was produced without the laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Augmedics Perc Pin Adaptor
The Issue: The perc pin adaptor AMCH07200 tightening knob was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microtek Patient Drape ECOLAB AP6MMN Patient Drape
The Issue: Due to non-sterile products being labeled as sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centerline Biomedical IOPS Guidewire 2
The Issue: Centerline Biomedical has determined that the coating on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iGo¿2 DC Car Adapter to be used with iGo¿2 Portable
The Issue: for DC Power Supply housing to become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pruitt Occlusion Catheter. Catalog Numbers: 2103-36
The Issue: During internal product testing, it was observed that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34
The Issue: During internal product testing, it was observed that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X)
The Issue: for the presence of visible foreign matter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09
The Issue: During internal product testing, it was observed that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN Craniotomy Kit
The Issue: Inadequate weld that can potentially cause the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN Disposable Perforator
The Issue: Inadequate weld that can potentially cause the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355
The Issue: Field action to clarify the flow rates and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Product Name: AirLife Infant Heated Wire Circuit
The Issue: Adapters may disconnect during setup or while in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS8000 Patient Monitor
The Issue: Patient monitor has nine identified cybersecurity vulnerabilities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.