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 15401–15420 of 38,428 recalls
Recalled Item: Heartware HVAD Pump Implant Kit
The Issue: The Outflow Graft may be subject to tears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartware HVAD Pump Implant accessories
The Issue: The Outflow Graft may be subject to tears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cranio/Sculpt C
The Issue: product mix-up. The recalling firm has determined
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary
The Issue: The lot number on the pediatric orthopedic implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as
The Issue: Observed an internal repetitive software glitch in ImmersiveView
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot
The Issue: When a user acquires XperCT scan on an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 -
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnipod DASH Insulin Management System (mg/dL configuration)
The Issue: After the device has been in use for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product...
The Issue: Incorrect shelf-life for bone void filler kits; the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerator APS Aliquoter Module
The Issue: In the case of an AQM clot detection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.