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 32921–32940 of 38,428 recalls
Recalled Item: Langston Dual Lumen Catheters
The Issue: The inner catheter of some Langston V2 Dual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FirmArray Blood Culture Identification (BCID) Panel
The Issue: BioFire has identified an increased risk of false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSI Cardiovascular Systems
The Issue: CSI has initiated a recall on the Diamondback
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns D4 Aortic Arch Cannulae 6.0mm
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Malleable Dual-stage Venous Return Cannulae 28/38
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Dual-stage Venous Return Cannulae 28/38
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Flexible Aortic Arch Cannula 8.0mm with luer
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500...
The Issue: RAPIDPoint 500 Measurement Cartridges may have an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPB Catheter Kit Product Usage: Venous Return Cannula is indicated
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Malleable Venous Return Cannulae 24
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Soft-Flow Aortic Cannulae 6.0mm
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Soft-arc Aortic Cannula 8.0mm curved tip
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo TenderFlow Pediatric Venous Cannulae
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology
The Issue: Black residue observed in the sterile pouch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer M/L Taper Hip Stem Standard & Extended Offset
The Issue: Black residue observed in the sterile pouch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer M/L Taper Reduced Neck Standard & Extended Offset
The Issue: Black residue observed in the sterile pouch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.