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 901–920 of 38,428 recalls
Recalled Item: Olympus Thunderbeat
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat 5 mm
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFire Respiratory Panel 2.1
The Issue: Due to unintended movement of pouch chemistry, nucleic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareLink Clinic
The Issue: Software error causing incorrect data to be displayed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VerifyNow PRUTest Platelet Reactivity Test UDI-DI code: 10711234150078
The Issue: Due to an device without a premarket clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System.
The Issue: for anesthesia leakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System.
The Issue: for anesthesia leakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HR-ACT (High Range Activated Clotting Time Cartridges)
The Issue: Medtronic personnel observed trace amounts of dry blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONARCH Bronchoscope. Model Number: MBR-000211-B
The Issue: that product was leak tested with equipment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emdogain
The Issue: The possibility for this product that is intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelePACS - InteleConnect / TechPortal
The Issue: Software application that receives digital images and data
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris infusion Pump Module 8100
The Issue: If infusion pump is dropped or severely jarred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit
The Issue: Device kits contained an incorrectly sized 4mm x
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an
The Issue: of negative recovery of the HBsAg analyte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multichem ID-B. Model Number: SR103B. Intended for use as an
The Issue: of negative recovery of the HBsAg analyte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions
The Issue: A potential issue with the seal integrity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions
The Issue: A potential issue with the seal integrity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.