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 15341–15360 of 38,428 recalls
Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch
The Issue: small holes at the seam lines of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch
The Issue: small holes at the seam lines of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral
The Issue: small holes at the seam lines of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inpeco FlexLab Centrifuge Module tube loading algorithm
The Issue: The FlexLab Centrifuge Module loading algorithm may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013
The Issue: If the shaft breaks due to material fatigue,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION EX
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH OSSILIX MP FIL
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRANIOSCULPT FLOW
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRANIOSCULPT FLOW
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATIONEX 5CC
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEOVATION RMX 10CC. Product Number: 390-6002
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SKAFFOLD CMF IMPRESS (MP)
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC BONE VOID FILLER
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH OSSILIX FIL (MX)
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH OSSILIX FIL (MX)
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRANIOSCULPT
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SKAFFOLD FLOW
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRANIOSCULPT
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.