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 6801–6820 of 38,428 recalls
Recalled Item: Multi-Mode Stimulator
The Issue: The instruction manuals that were included with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTUM TTC BILIARY BALLOON DILATOR
The Issue: Nonconforming devices while manufactured correctly, do not comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTUM TTC BILIARY BALLOON DILATOR
The Issue: Nonconforming devices while manufactured correctly, do not comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remington MEDICAL Drainage Bag
The Issue: There is an error with the "Use by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTUM TTC BILIARY BALLOON DILATOR
The Issue: Nonconforming devices while manufactured correctly, do not comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICM LNQ22 LINQ II
The Issue: It may create the potential for amplified noise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sperm separation media are used to separate motile sperm from
The Issue: The lower layer component of a sperm separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biolox Ceramic Option Head Zimmer 12/14 40mm +0
The Issue: One product complaint was received reporting that there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biolox Ceramic Option Head Zimmer 12/14 40mm -3
The Issue: One product complaint was received reporting that there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian 2 System Product Name: Guardian System 2
The Issue: A software issue where "low" and "terminal" battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Oasis Drain Single W / AC
The Issue: A sterilization nonconformance prematurely aged the product by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LITe Decompression Snake Arm
The Issue: Product arm was manufactured with the incorrect clamp
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4
The Issue: Under certain circumstances, information from HL7 messages received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump
The Issue: In affected products, the tubing outer diameter may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADLT BLOOD CULTURE COLLECT KIT
The Issue: This recall is being issued due to items
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERIPHERAL BLOOD CULTURE DRAW
The Issue: This recall is being issued due to items
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BLOOD CULTURE KIT
The Issue: This recall is being issued due to items
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 24 BLOOD CULTURE KIT
The Issue: This recall is being issued due to items
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CENTRAL LINE BLOOD CULTURE DRA
The Issue: This recall is being issued due to items
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZEUS ELISA Parvovirus B19 IgM Test System
The Issue: The organization completed a product improvement process to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.