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 3381–3400 of 38,428 recalls
Recalled Item: Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1 ) KIT
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK
The Issue: endotoxin contamination in non-sterile surgical strips and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
The Issue: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O&M Halyard Procedure Mask with SO SOFT* Earloops
The Issue: Not meeting the bioburden testing requirements of EN
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O&M Halyard SOFT TOUCH II Surgical Mask
The Issue: Not meeting the bioburden testing requirements of EN
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer
The Issue: The reason for the recall is that EDTA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiaSorin LIAISON Q.S.E.T. Device Plus
The Issue: Customer complaints were received alleging leaking devices and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model
The Issue: Due to a data migration from on-premises server
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline brand
The Issue: Surgical Patties & Surgical Strips in specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20/30 Priority Pack Accessory Kit w/Copilot
The Issue: Inflation Device used during cardiovascular procedures may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT
The Issue: Surgical Patties & Surgical Strips in specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SEPTOPLASTY PACK Convenient kit
The Issue: Surgical Patties & Surgical Strips in specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20/30 Priority Pack Accessory Kit/.096 RHV
The Issue: Inflation Device used during cardiovascular procedures may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline brand
The Issue: Surgical Patties & Surgical Strips in specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIEP FLAP Convenience kit
The Issue: Surgical Patties & Surgical Strips in specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FESS-MB PACK-LF Convenience kit
The Issue: Surgical Patties & Surgical Strips in specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20/30 INDEFLATOR
The Issue: Inflation Device used during cardiovascular procedures may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20/30 Priority Pack Kit/.115 RHV
The Issue: Inflation Device used during cardiovascular procedures may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.