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 33621–33640 of 38,428 recalls
Recalled Item: Cobas c8000 Modular Analyzer Series Cobas c502
The Issue: The Initial Cassette Volume Check (ICVC) is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5X250 MM Curved Cannula
The Issue: Intuitive Surgical has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5X300 MM Curved Cannula
The Issue: Intuitive Surgical has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Custom Syringe Kit
The Issue: The products are labeled as sterile but were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Monitoring Tubing
The Issue: The products are labeled as sterile but were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace Portal (ISP)
The Issue: During SPECT reconstructions using Attenuation Correction and Scatter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless
The Issue: Product does not meet minimum needle attachment strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical
The Issue: Product does not meet minimum needle attachment strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Medical
The Issue: Product does not meet minimum needle attachment strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Medical
The Issue: Product does not meet minimum needle attachment strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonabsorbable Surgical Suture
The Issue: Product does not meet minimum needle attachment strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture
The Issue: Product does not meet minimum needle attachment strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Fixt Suture Braided Polyester
The Issue: Product does not meet minimum needle attachment strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPIO
The Issue: The product did not meet minimum and/or average
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dekna-lok
The Issue: The product did not meet minimum and/or average
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monofilament and Multifilament Non-absorbable Steel Suture
The Issue: The products are being recalled because they did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monodek Violet Synthetic Absorbable Surgical Sutures
The Issue: Product does not meet minimum knot tensile strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port
The Issue: Complaints of leakage of insufflation gas through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10mm Weck Vista Cannula-only
The Issue: Complaints of leakage of insufflation gas through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access
The Issue: Complaints of leakage of insufflation gas through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.