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 19781–19800 of 38,428 recalls
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mitek Screw and Washer Depth Gauge
The Issue: The device has an offset in the design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer with Cross Enterprise Display This impacts product
The Issue: Remote comparison studies displayed may be associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mindray BeneVision Distributed Monitoring System (DMS)
The Issue: The firm has identified performance anomalies with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine
The Issue: Firm received sporadic reports of discoloration on certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunset Compressor Nebulizer
The Issue: The product was designed for 120V usage and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software...
The Issue: Quality control results are not processed for Abbott
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INSORB SUBCUTICULAR SKIN STAPLER
The Issue: compromise of the sterile barrier integrity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott ARCHITECT cSystems ICT Module
The Issue: There is a potential to generate falsely elevated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2
The Issue: The reagent pack exhibits the potential for an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hoffman LRF Hexapod Strut
The Issue: The press fit connection of the Angular Sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hoffman LRF Hexapod Strut
The Issue: The press fit connection of the Angular Sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hoffman LRF Hexapod Strut
The Issue: The press fit connection of the Angular Sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hoffman LRF Hexapod Strut
The Issue: The press fit connection of the Angular Sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyPass System 241-S
The Issue: Analysis of the completed dataset from the COMPASS-XT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyPass System 241
The Issue: Analysis of the completed dataset from the COMPASS-XT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.