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 301–320 of 38,428 recalls
Recalled Item: Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE
The Issue: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF
The Issue: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS
The Issue: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY
The Issue: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure convenience kits labeled as: 1) ROBOTIC
The Issue: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estrone RIA
The Issue: The affected Estrone RIA kit lots may rarely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
The Issue: Presence of particulates in affected devices that can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Nasal Jejunal Feeding Tube
The Issue: Nasal feeding tube packaged without the nasal transfer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape
The Issue: Product contains potentially harmful dosing errors for Vecuronium,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Broselow Product Name: Broselow Domestic Complete ALS Organizer
The Issue: Product contains potentially harmful dosing errors for Vecuronium,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog
The Issue: Product contains potentially harmful dosing errors for Vecuronium,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape
The Issue: Product contains potentially harmful dosing errors for Vecuronium,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Plum Duo Infusion Pump
The Issue: Plum Solo and Duo Infusion pumps include a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Plum Solo Precision IV Pump
The Issue: Plum Solo and Duo Infusion pumps include a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number:
The Issue: The console label for affected devices is missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Plum Duo Precision IV Pump
The Issue: Plum Solo and Duo Infusion pumps include a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TS-10/TS-10H Tube Sorter
The Issue: Under specific conditions, the lift's electromagnetic holding force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci SP
The Issue: Access Port System tray may develop cracks potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10F
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10/10
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.