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 7461–7480 of 38,428 recalls
Recalled Item: TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT
The Issue: A complaint was received indicating that a package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambu aView 2 A Monitor-The Ambu aView 2 Advance is
The Issue: Multiple impacts, for example from being dropped, can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to
The Issue: A bottle of Copaliner Solvent was inadvertently packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenition 70. The device is to be used in health
The Issue: Philips has become aware of the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cosmedent FlexiCup Composite Finishing & Polishing System
The Issue: Reports were received the elastomer cup material is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: For intraventricular indications mainly used for operations within the brain
The Issue: Trocar manufactured with the shaft too long and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visera Hysterovideoscope Olympus HYF Type V
The Issue: IFU labeling is being updated to revise EtO
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHOROPTOR VRX DIGITAL SYSTEM-Digital intended for the subjective
The Issue: Phoroptor VRx Head may detach from the bracket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOxBOXi Nitric Oxide Delivery System
The Issue: Replacement of the internal Sample Pump due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freedom Boom models series: F110
The Issue: Weakened connection point on the adjustable suspension arm,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper series
The Issue: A foot switch pedal may get stuck in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion
The Issue: A foot switch pedal may get stuck in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiDiagnost-Eleva
The Issue: A foot switch pedal may get stuck in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product...
The Issue: As part of the firm's ongoing quality monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preat
The Issue: The healing abutments contain a dimensional condition that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preat
The Issue: The healing abutments contain a dimensional condition that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preat
The Issue: The healing abutments contain a dimensional condition that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim" XR 7 Implantable Pulse Generator (previously known
The Issue: Firm has received complaints from patients who are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim Plus 5 Implantable Pulse Generator Product Description:
The Issue: Firm has received complaints from patients who are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim XR 5 Implantable Pulse Genterator (previously known
The Issue: Firm has received complaints from patients who are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.