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 4781–4800 of 38,428 recalls
Recalled Item: Bag Decanter II
The Issue: During sterile barrier testing performed on the decanter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vial Decanter
The Issue: During sterile barrier testing performed on the decanter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bottle Decanter
The Issue: During sterile barrier testing performed on the decanter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Flow Bag Decanter
The Issue: During sterile barrier testing performed on the decanter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transfer Device
The Issue: During sterile barrier testing performed on the decanter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAcube Connect MDx - IVD Instrument designed to perform automated
The Issue: Heater shaker module does not perform heating if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTL190395: 2008K@HOME MACHINE
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn CP150 Electrocardiograph with Spirometry Option
The Issue: During manufacturing, the step to install an Electromagnetic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTLR190395: 2008K@HOME MACHINE
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 190395: 2008K@HOME MACHINE
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Non-Sterile Flyte hood covers the user s head and
The Issue: Expired Products distributed to customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neurostimulation Kit (Ported
The Issue: Neurostimulation Systems have a manufacturing non-conformance that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: This product is a single use sterile device that is
The Issue: Expired Products distributed to customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curved
The Issue: Expired Products distributed to customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscopic Kittner Blunt Dissecting Instrument
The Issue: The affected products may have been packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.