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 16401–16420 of 38,428 recalls
Recalled Item: NATRELLE Resterilizable Sizers for the styles and sizes: Style 15
The Issue: The firm has became aware that 2D barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Color Cuff Disposable Tourniquet Cuff
The Issue: There is a potential for the cuff to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Color Cuff Disposable Tourniquet Cuff
The Issue: There is a potential for the cuff to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dako Autostainer instruments: Autostainer Link 48
The Issue: The Autostainer instrument may not have a syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: King Vision Video Adapter Size 1/2. Laryngoscope used to examine
The Issue: Exhibiting a reversed image. Although the image may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIBSON Healthcare Membrane Extended
The Issue: The products may have been packaged with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIBSON Healthcare Membrane Extended
The Issue: The products may have been packaged with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIBSON Healthcare Membrane 6-9
The Issue: The products may have been packaged with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIBSON Healthcare Membrane 6-9
The Issue: The products may have been packaged with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIBSON Healthcare Membrane 6-9
The Issue: The products may have been packaged with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIBSON Healthcare Membrane Extended
The Issue: The products may have been packaged with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Haylard Closed Suction System for Neonates/Pediatrics
The Issue: Avanos Medical has received reports stating that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinias DAP Meter
The Issue: The DAP meters were found to be outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Histoplasma Immunodiffusion (ID) Antigen
The Issue: False positive results due to potential contamination of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8mm HTR Sterile Hammer Toe Reaming Kit
The Issue: The firm has identified that parts from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS
The Issue: Certain lot numbers of the Medacta Humeral Anatomical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Juno DRF
The Issue: An amendment to the IFU and Service Manual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo EZ
The Issue: An amendment to the IFU and Service Manual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo DRF
The Issue: An amendment to the IFU and Service Manual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo
The Issue: An amendment to the IFU and Service Manual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.