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 35121–35140 of 38,428 recalls
Recalled Item: ACL TOP 300 and ACL TOP 300 CTS (Japan)
The Issue: carryover issue that can can cause shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 500 CTS
The Issue: carryover issue that can can cause shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 700 LAS
The Issue: carryover issue that can can cause shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated
The Issue: Covidien Neurovascular has initiated the recall of several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blue Belt Technologies
The Issue: Blue Belt Technologies is recalling sterile Monitor Drapes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-QUR Edge Mesh (All sizes and shapes). Intended for use
The Issue: Additional Instructions for Use and Storage Conditions as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-QUR V-Patch Mesh (All sizes and shapes). Intended for use
The Issue: Additional Instructions for Use and Storage Conditions as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-QUR Mesh (All Sizes
The Issue: Additional Instructions for Use and Storage Conditions as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-QUR TacShield Mesh (All sizes and shapes). Intended for use
The Issue: Additional Instructions for Use and Storage Conditions as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMUS
The Issue: Siemens has become aware of a customer complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure
The Issue: Aspen Surgical is recalling Wound Closures because firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Temperature Probes
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous
The Issue: The labeling states that the kit contains Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter
The Issue: Arrow is recalling the Arrowgard Blue Plus Antimicrobial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: LIST NO. 43449
The Issue: Hospira has recieved reports that the vacuum needed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid
The Issue: Beckman Coulter has received a customer complaint that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers:
The Issue: Medtronic was notified that Edwards Lifesciences has initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Leyla Ball Joint Clamp
The Issue: As a result of complaint investigations it was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Perfusion System. Model Numbers: 1D80R8
The Issue: Medtronic was notified that Edwards Lifesciences has initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing
The Issue: Medtronic was notified that Edwards Lifesciences has initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.