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 13781–13800 of 38,428 recalls
Recalled Item: RayStation 4
The Issue: Two issues were found with the treatment plan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instruction Manual for Mayfield A2000 Skull Cap - Product Usage:
The Issue: Revised Instruction Manual to reflect the most accurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance
The Issue: The radio within the device can become disassociated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniCap Extended Life PD Transfer Set
The Issue: for no-flow and leaks under the twist
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Code: K05T-02533
The Issue: Angiography/Angioplasty custom kits contain header bags which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Procedure Kit
The Issue: Angiography/Angioplasty custom kits contain header bags which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Code: K12T-02871
The Issue: Angiography/Angioplasty custom kits contain header bags which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved
The Issue: On November 10, 2020, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter
The Issue: The products subject to this recall may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved
The Issue: On November 10, 2020, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROKERA Plus
The Issue: exposure of product to microbial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROKERA
The Issue: exposure of product to microbial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROKERA Slim
The Issue: exposure of product to microbial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Humeral Stem
The Issue: for incorrect Instructions For Use (IFU) included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for
The Issue: Due to a potential software issue, the display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure packs
The Issue: Gauze sponges contained in custom kits may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-ACT Actalyke Clotting Test Tubes that are used in the:
The Issue: Due to complaints received associated with cracked/split test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shimadzu Mobile X-Ray System
The Issue: There is a potential that the adjustable handle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion Prime SP
The Issue: A software problem has been identified which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaturaLyte Liquid Acid concentrate drums
The Issue: The sodium and/or calcium levels in these concentrates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.