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 3441–3460 of 38,428 recalls
Recalled Item: Achieva TX Interventional Coil 3.0T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FACSLyric 2L4C Instrument US
The Issue: On October 18, 2024, BD has identified through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FACSLyric 3L12C Instrument RUO
The Issue: On October 18, 2024, BD has identified through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FACSLyric 3L10C Instrument US-IVD
The Issue: On October 18, 2024, BD has identified through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FACSLyric 3L8C Instrument US-IVD
The Issue: On October 18, 2024, BD has identified through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Device Description: FACSLyric 2L6C Instrument US
The Issue: On October 18, 2024, BD has identified through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA
The Issue: Due to complaints received reporting cracks and/or leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER
The Issue: Due to complaints received reporting cracks and/or leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown
The Issue: Isolation Gowns were manufactured with raw materials that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convertor Isolation Gown
The Issue: Isolation Gowns were manufactured with raw materials that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial Server Software Versions 11.1.4 through 11.1.6
The Issue: Certain software versions will not notify end users
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kreatech PapV-16
The Issue: The DNA fragments for this specific lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC FX
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hybrid Recon software on Hermes Medical Imaging Suite version 6.1
The Issue: Due a potential software/configuration issue that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX System
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm)
The Issue: Patients implanted with synthetic cartilage implant, may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD EpiCenter Single User Software Version or Model: 441007 Catalog
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD EpiCenter Data Management System
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.