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 9901–9920 of 38,428 recalls
Recalled Item: Disc Preparation instruments contained in the following products:...
The Issue: Due to manufacturing instruments which included additional features
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES SARS-CoV-2 Assay
The Issue: A part defect with the wash 1 syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex HF20 Set (product code 109841). For use in providing
The Issue: Within the current Prismaflex set IFU (instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex ST Set: ST60 (product code 107643)
The Issue: Within the current Prismaflex set IFU (instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex M Set: M60 (product code 106696)
The Issue: Within the current Prismaflex set IFU (instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex M Set: M150 (product code 109990). For use in
The Issue: Within the current Prismaflex set IFU (instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex HF Set: HF1000 (product code 107140)
The Issue: Within the current Prismaflex set IFU (instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovoTHOR Gen 2.5 Regular whole body red light therapy bed
The Issue: Failure of ball stud components causing the gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovoTHOR Gen 2.0 whole body red light therapy bed
The Issue: Failure of ball stud components causing the gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G041 POD
The Issue: Failure of ball stud components causing the gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovoTHOR Gen 2.5 XL whole body red light therapy bed
The Issue: Failure of ball stud components causing the gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthex Large Bone Shoulder Bolt
The Issue: Bolt breakage on the head or threaded portion,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ADLT BLOOD CLUTURE COLLECT KIT
The Issue: Adult Blood Culture Collect kit and Pre-Op Changing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE PHERIPHERAL BLOOD CULTURE DRAW
The Issue: Adult Blood Culture Collect kit and Pre-Op Changing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
The Issue: Adult Blood Culture Collect kit and Pre-Op Changing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE BLOOD CLUTURE KIT
The Issue: Adult Blood Culture Collect kit and Pre-Op Changing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE 24 BLOOD CLUTURE KIT
The Issue: Adult Blood Culture Collect kit and Pre-Op Changing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: The display screen may become frozen and unresponsive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR
The Issue: An increase in clip locking malfunctions, Establish Final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.