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 441–460 of 38,428 recalls
Recalled Item: BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip
The Issue: Labeling error, Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0...
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan. Model/Catalog Numbers: 12.0.0
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan. Model/Catalog Numbers: 11.0.0
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA Spectrum Infusion Pump
The Issue: Certain pumps have potentially been released from service
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1...
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version:...
The Issue: for the invalidation for calculated radiation dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HiResolution Bionic Ear System Product Name: Sky CI
The Issue: Behind-the-ear sound processer packaging label is different then
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed
The Issue: Medline Industries has identified a potential hazard involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed
The Issue: Medline Industries has identified a potential hazard involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed
The Issue: Medline Industries has identified a potential hazard involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed
The Issue: Medline Industries has identified a potential hazard involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed
The Issue: Medline Industries has identified a potential hazard involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed
The Issue: Medline Industries has identified a potential hazard involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump
The Issue: Medline kits contain B. Braun IV Administration Sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump
The Issue: Medline kits contain B. Braun IV Administration Sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.