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 25681–25700 of 38,428 recalls
Recalled Item: ViaPeel PTFE Peelable Introducer 5FR
The Issue: Greatbatch received complaints with the ViaPeel Introducer Sheath
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew
The Issue: Lack of 510k clearance for design modification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew
The Issue: Lack of 510k clearance for design modification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic
The Issue: An increase in reports indicating that the reprocessed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterling Nitrile Sterile Powder Free Exam Gloves
The Issue: Defects: Product may be discolored and brittle resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3
The Issue: Medtronic identified an issue with specific models and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay
The Issue: Shipping error. Cocaine metabolite Microplate distributed instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GAM Kirschner Wire
The Issue: A review of packaging revealed the seal integrity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 4.0
The Issue: Software anomaly; an issue was found with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Virtual XD Test Pack Heavy/Light Fast Set
The Issue: The firm received complaints claiming the dental material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elana Surgical KitHUD The Elana Surgical KitHUD
The Issue: Elana has issued this Field Action to voluntarily
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile)
The Issue: Drapes within the affected lots may include a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Virtual XD Light Body Regular Set Wash Material
The Issue: The firm received complaints claiming the dental material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Virtual XD Light Body Fast Set Wash Material
The Issue: The firm received complaints claiming the dental material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SWANSON GREAT TOE
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VALOR SCREW 5.0MM X 45MM LEN
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHOLOC 3DI PLT SYS STERILE
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRO-STIM 10cc INJECTABLE
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Darco STERILE HEADED DRILL BIT 4.4MM
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SWANSON FINGER JOINT #1
The Issue: The firm discovered a lack of adequate documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.