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 22341–22360 of 38,428 recalls
Recalled Item: ECOLAB MICROTEK Rolled Probe Cover
The Issue: The incorrect IFU was shipped with the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECOLAB MICROTEK Rolled Probe Cover
The Issue: The incorrect IFU was shipped with the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane
The Issue: The kit was packaged with the incorrect guidewire
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProLite Mesh - mesh
The Issue: An incorrect ProLite Mesh configuration was packaged as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Legacy 1
The Issue: Certain CADD Legacy 1, Ambulatory Infusion Pumps, may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Santajoy Ornament & Giftware Co.
The Issue: It was discovered that the product units it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series
The Issue: Rechargeable lithium-ion batteries with incorrect firmware that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wash Kit () Lots 16279
The Issue: The firm has initiated a field recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OCULUS Pentacam AXL
The Issue: The device software versions have an anomaly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 ML REAGENT CUP
The Issue: The ABX PENTRA Reagent Containers do not always
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 15 ML REAGENT CUP
The Issue: The ABX PENTRA Reagent Containers do not always
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 3.5
The Issue: When calculating electron Monte Carlo dose with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring
The Issue: While in Full Disclosure playback, a user may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phadia Prime software
The Issue: We want to inform all Phadia 250 system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apex Knee System
The Issue: The Apex Knee System Tibial Baseplate identified has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integrity R1.2
The Issue: for positional errors following automatic table movement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agility with Integrity R3.2
The Issue: for positional errors following automatic table movement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tapered Screw-Vent MTX Model TSVTB11
The Issue: Some implant vial caps in the recalled implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Telemetry Transmitter
The Issue: Firm became aware that it distributed 7 units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Specimen Gate Screening Center
The Issue: errors in patient results generated by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.