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 1361–1380 of 38,428 recalls
Recalled Item: CLEARLINK SYSTEM EXTENSION SET
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK System Non_DEHP Extenstion Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DuoDERM" Extra Thin dressings are highly flexible
The Issue: Wound dressing may have foreign matter on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM EXTENSION SET
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound...
The Issue: Production assembly error resulting in the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX
The Issue: To provide further information to the user to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
The Issue: for device to overheat during operation if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model
The Issue: for breaches in the sterile barrier packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product is a handheld ultraviolet-C germicidal wand and contains
The Issue: The subject product emits unsafe level of UVC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.