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 7221–7240 of 38,428 recalls
Recalled Item: BD Pyxis CII Safe ES
The Issue: When global edit is used to update multiple
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T HD SYS. CDX BLUESTAR
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Venue Go Standard Carts Ref: (H45181VC and H45103VCW)
The Issue: Some Venue Go Standard Carts can develop an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Meera Mobile Operating Table-to support and position the patient immediately
The Issue: Under certain conditions, an issue might prevent the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Oasis Dry Suction Water Seal Chest Drain
The Issue: Product was re-processed and re-sterilized by a third
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Oasis Dry Suction Water Seal Chest Drain
The Issue: Product was re-processed and re-sterilized by a third
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAZOR X robotic guidance system
The Issue: Software update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use
The Issue: Skin grafts thin and non-uniform when using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethos Collar Stem
The Issue: for breach of Tyvek seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. Segmental Stem
The Issue: for breach of Tyvek seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Segmental Stem
The Issue: for breach of Tyvek seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Segmental Stem
The Issue: for breach of Tyvek seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Male-Female Midsection with the following sizes and model numbers. a.
The Issue: for breach of Tyvek seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Segmental Stem
The Issue: for breach of Tyvek seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Guardian System Product Name: The Guardian Model/Catalog
The Issue: Device reaching End of Service prematurely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solea Models 2.0 and 3.0 Laser Surgical Instrument
The Issue: It has been found that potential unintended laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAVH
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Robotics Pack SAH
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Robotics Pack
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vasc. Open CVOR SJH
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.