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 8781–8800 of 38,428 recalls
Recalled Item: CardioMEMS HF System PA Sensor and Delivery System
The Issue: Select CardioMEMS PA Sensors (Model CM2000) operate outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS HF System Hospital Electronics System (HES)
The Issue: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS HF System Patient Electronics System (PES)
The Issue: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS HF System Patient Electronics System (PES)
The Issue: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: There have been reported failures of the high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
The Issue: An unexpected shutdown of the IABP may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
The Issue: An unexpected shutdown of the IABP may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS HF System Patient Electronics System (PES)
The Issue: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
The Issue: An unexpected shutdown of the IABP may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Hoffmann LRF
The Issue: Stryker has identified a nonconformance in specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 Acetabular System
The Issue: The outer package labeling and product etch are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial mobile application
The Issue: The mobile application for Android devices downloaded from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix mKDR Xpress
The Issue: Sedecal was informed of 3 incidents of erratic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA comprises AST Filters in conjunction with VITEK MS
The Issue: For users with MYLA V4.8.X / V4.9 that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix mKDR
The Issue: Sedecal was informed of 3 incidents of erratic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avanos Ballard Oral Care Swab
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sit to Stand STS500 Patient Lift
The Issue: Risk of boom pivot failing due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL ELITE designed specifically for clinical use in the
The Issue: Removes the test definition for HemosIL Liquid Anti-Xa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL ELITE PRO-Analyzer designed specifically for clinical use in the
The Issue: Removes the test definition for HemosIL Liquid Anti-Xa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL ELITE- Analyzer designed specifically for clinical use in the
The Issue: Removes the test definition for HemosIL Liquid Anti-Xa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.