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 9921–9940 of 38,428 recalls
Recalled Item: cobas 5800 instrument
The Issue: Reported false positive and invalid results on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR
The Issue: An increase in clip locking malfunctions, Establish Final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT
The Issue: An increase in clip locking malfunctions, Establish Final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH
The Issue: The kits are being recalled due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter
The Issue: Manufacturing error resulted in potential contamination of Bi-Directional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CENTURION SnagFree Chest Tube insertion Tray
The Issue: One lot of chest tube insertion trays, containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima Coil System Model Number OPTI0208CSS10
The Issue: Product pouch label does not match up with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wisp and Wisp Youth Nasal Mask
The Issue: No contraindication/warning regarding magnetic components in CPAP masks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DreamWisp Nasal Mask with Over the Nose Cushion
The Issue: No contraindication/warning regarding magnetic components in CPAP masks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics Amara View Minimal Contact Full-Face Mask
The Issue: No contraindication/warning regarding magnetic components in CPAP masks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR Patient Care Portal 5000 (Desktop Unit)
The Issue: Device may intermittently fail to produce audio. Turning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Therapy Mask 3100 NC/SP
The Issue: No contraindication/warning regarding magnetic components in CPAP masks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics DreamWear Full Face Mask
The Issue: No contraindication/warning regarding magnetic components in CPAP masks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clip COVID Rapid Antigen Test Kit (25-pack)
The Issue: COVID test kit shelf life was periodically extended,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hu-Friedy K360 Scalpel Handle
The Issue: The scalpel holder may separate from the handle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Starling Monitor
The Issue: Labeling has incorrect or incomplete Unique Device Identification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Recreo Hair Growth Laser Comb
The Issue: The firm distributed the laser products without affixing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Surgical Level 3 Gown
The Issue: Surgical gowns recalled due to gown fabric failing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Introcan Safety FEP 14G
The Issue: for leakage at the catheter hub
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENCLOSE
The Issue: Impacted Venclose Procedure Packs contain a 12cm introducer/sheath
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.