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 1821–1840 of 38,428 recalls
Recalled Item: DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination
The Issue: Due to manufacturing error, assay test may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxI 600 Access Immunoassay Analyzer
The Issue: Beckman Coulter has identified that the UniCel DxI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxI 800 Access Immunoassay Analyzer
The Issue: Beckman Coulter has identified that the UniCel DxI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP Primary Administration Set
The Issue: for external cassette leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP Blood Products Administration Set Dual-Inlet
The Issue: for external cassette leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PILLAR SA Ti
The Issue: A 37 mm implant width intervertebral body fusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP Primary Administration Set
The Issue: for external cassette leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP Primary Administration Set
The Issue: for external cassette leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preat
The Issue: Due to manufacturing error, digital analog rotational feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate Product Name: Mobile Power Unit
The Issue: Due to misaligned V-Lock feature on the Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:
The Issue: Due to misaligned V-Lock feature on the Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated Impella Controller (AIC)
The Issue: A potential issue with the Automated Impella Controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical
The Issue: The DFPM yoke assembly ("yoke assembly") may detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical
The Issue: The DFPM yoke assembly ("yoke assembly") may detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD COR System Software. Model Number: 444829.
The Issue: for functionality issue that supports the Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Nellcor Bedside SpO2 Patient Monitoring System:
The Issue: Bedside SpO2 Patient Monitoring System alarms not heard/recognized,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: One-piece Guedel airway
The Issue: contamination with small burrs, which if detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE SIGNA Premier Elite (China Only)
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Signa Artist
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE SIGNA Premier XT (China Only)
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.