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 5801–5820 of 38,428 recalls
Recalled Item: STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device:...
The Issue: Degraded and unusable upon removal from the foil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INNOMED CUP REMOVAL STARTER INSTRUMENT
The Issue: 54 MM finisher blade was inadvertently affixed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POWERSEAL 5 mm
The Issue: Upon initial activation of the seal function, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POWERSEAL 5 mm
The Issue: Upon initial activation of the seal function, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POWERSEAL 5 mm
The Issue: Upon initial activation of the seal function, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP Software of the Ivenix Infusion System (IIS)
The Issue: Software has anomalies that have the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tablo Hemodialysis System
The Issue: Hemodialysis System, pre and post dialyzer peroxide-cured silicone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CryoValve SG Cryopreserved Pulmonary Human Heart Valve
The Issue: The blood cultures performed as part of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b
The Issue: The positive control material (Rhizopus stolonifer) within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe CAGE GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe CAGE GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.