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 15381–15400 of 38,428 recalls
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: SKAFFOLD RENU FLOW
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10
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: ACUMED IMPACT 10CC. Product Number: 65-0110-S
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUMED IMPACT 5CC. Product Number: 65-0105-S
The Issue: Bone void filler kits may not maintain its
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 FORM (MX)
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 FORM (MX)
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SKAFFOLD RENU FLOW
The Issue: Bone void filler kits may not maintain its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
The Issue: Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Brilliance iCT SP Computed Tomography X-Ray System
The Issue: The bolt affixing the cooling unit to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Brilliance iCT Computed Tomography X-Ray System
The Issue: The bolt affixing the cooling unit to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System AXIOM Aristos FX - Product Usage: A dedicated x-ray
The Issue: It was determined that in rare cases persons
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Brilliance IQon Spectral CT
The Issue: The bolt affixing the cooling unit to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System AXIOM Aristos FX Plus - A dedicated x-ray system
The Issue: It was determined that in rare cases persons
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
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: VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07
The Issue: While transferring blood the needle may dislodged and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartware HVAD Pump Outflow Graft
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 Kit
The Issue: The Outflow Graft may be subject to tears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.