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 29381–29400 of 38,428 recalls
Recalled Item: Nipro Safe Touch TULIP Safety Fistula Needle
The Issue: Some 1 1/4" needles were packaged and labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XGAUZE Trauma Dressing
The Issue: The XGAUZE Trauma Dressing was recalled because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIRMap 60mm Catheter
The Issue: The expiration date was incorrectly printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2
The Issue: Otto Bock Healthcare Products GmbH is recalling the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 23G and 25G Constellation Totalplus Paks provides access into the
The Issue: The product has potential to leak beyond their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Paks containing 23G and 25G valved trocar cannula provide
The Issue: The product has potential to leak beyond their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon 23G and 25G Valved Entry System provides access into
The Issue: The product has potential to leak beyond their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Universal Locking System
The Issue: It was found through review of open Complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo RT Oncologist
The Issue: This update is intended to provide a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm
The Issue: DLS pin breakage during planned implant removal, after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer Product Usage: The Centricity Universal Viewer...
The Issue: Images from the Centricity PACS-IW with Universal Viewer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LX3 Floor Stand for Endure Luxite Envision Optical System
The Issue: Alcon is initiating a voluntary recall of all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW
The Issue: Images from the Centricity PACS-IW with Universal Viewer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver
The Issue: The RASH3N, a hexed, abutment screw driver tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips
The Issue: RASQ3N, a square, abutment screw driver tip has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIDEX OPA Solution
The Issue: Advanced Sterilization Products (ASP) is reminding all CIDEX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crocodile Grasper
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fundus Grasper
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medium -Large Clip Applier
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cadiere Forceps
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.