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 1381–1400 of 38,428 recalls
Recalled Item: Dexcom G6 Continuous Glucose Monitoring System Product Name:
The Issue: A software defect in version v1.15.0 of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sharesource Connectivity Platform for Use with Homechoice Claria Product Code
The Issue: Vantive has identified a software defect within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mMR. Model Number: 10433372.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Prisma. Model Number: 10849582.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOGRAPH One (DE). Model Number: 11689172.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Verio. Model Number: 10276755.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Lumina (DE). Model Number: 11344916.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. EXETER V40 STEM 44MM NO 2
The Issue: a potential product mix where the package labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number:
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Vida Fit. Model Number: 11410481.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Skyra fit. Model Number: 10849580.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Cima.X (DE). Model Number: 11647158.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Connectom.X. Model Number: 11371480.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Verio Dot. Model Number: 10684333.
The Issue: There is a potential for an ice blockage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extractor Pro RX Retrieval Balloon Catheter
The Issue: The product in incorrectly labeled. The label indicates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The AlignRT InBore system contains six Class 1 lasers which
The Issue: Vision RT is informing customers of an omission
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.