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 2761–2780 of 38,428 recalls
Recalled Item: Medline procedure kits labeled as: 1) DELIVERY PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) ARTHROSCOPY PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) A & A KNEE PACK-LF
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) CT BIOPSY PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) ANGIO PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) L S GYN PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) C SECTION
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) BREAST PACK-LF
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS Software Version 7.4.x
The Issue: The incorrect computed patient age is showing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) EYE PACK
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits labeled as: 1) C SECTION
The Issue: Medical convenience kits contain plastic syringes affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Candida ID Antigen
The Issue: Candida Immunodiffusion Antigen may have reduced sensitivity which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Origin Data Management software versions 3.1.0
The Issue: Under certain circumstances, it can occur that patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom Pak with Non-Latex Symbol
The Issue: Customer-designed sterile surgical procedure packs contain latex components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bodor's I series laser cutting machine.
The Issue: The Bodor i Series products fail to meet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.