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 24041–24060 of 38,428 recalls
Recalled Item: Access Total T3
The Issue: The Access immunoassays are susceptible to biotin interference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code:
The Issue: Cotton tip of the device may disengage due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access System-Free T4 Assay
The Issue: The Access immunoassays are susceptible to biotin interference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Pressure Injectable PICC Kit Catheter
The Issue: The Arrow Pressure Injectable PICC is intended for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Introducer Kit with Integral Hemostasis Valve/Side Port
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arterial Catheterization Kit
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2)...
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2)
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Multi-Use Holmium Laser Fibers
The Issue: Correction to the product Instructions for Use because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The
The Issue: Arrow International is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access
The Issue: The Arrow CVC is indicated to provide short-term
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended
The Issue: The Arrow CVC is indicated to provide short-term
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI
The Issue: Incorrect labeling; the box label indicates Pediatric, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas connection module (CCM) - OUTPUT UNIT The module CCM
The Issue: a gap between the conveyor belt and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beekley Medical 0-SPOT Mammography Skin Markers
The Issue: Mammography Skin Marker 0 -SPOT (REF 652) product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrophysiology catheter cables are designed as electrode cables with a
The Issue: Sterilmed is recalling all lots of specific product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.