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 31761–31780 of 38,428 recalls
Recalled Item: Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION...
The Issue: ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are
The Issue: ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Cabinet X-ray systems
The Issue: GE discovered these cabinet x-ray systems' potential failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250
The Issue: Software defect that causes an incorrect dose compensation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Nerve Block Component
The Issue: Arrow is recalling certain lots of the Continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal...
The Issue: Software defect. In certain circumstances, the application may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7
The Issue: Tubing detachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AC TenderLink 13/30 10 pcs
The Issue: Tubing detachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contact Detach
The Issue: Tubing detachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Silhouette Paradigm 13mm
The Issue: Tubing detachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureT G29 6mm
The Issue: Tubing detachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusion Set
The Issue: Tubing detachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
The Issue: Unintended treatment termination could result from a keypad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Viper LT System
The Issue: for false positive Chlamydia trachomatis (CT) results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSSEOTITE Tapered Certain Implant Rx Only
The Issue: Endosseous Dental Implants in contact with a residual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSSEOTITE Certain 2 Implant Rx only
The Issue: Endosseous Dental Implants in contact with a residual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3i T3 Non-Platform Switched Tapered Implant Rx Only
The Issue: Endosseous Dental Implants in contact with a residual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: adaPT insight (12C)
The Issue: Two issues were identified: 1. In the release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ceramic Femoral Head. Intended for use in total hip arthroplasty
The Issue: Two complaints reported that the BIOLOX delta TS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue
The Issue: Due to a complaint, it was determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.