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 7061–7080 of 38,428 recalls
Recalled Item: Abbott NT2000iX Radiofrequency (RF) generator
The Issue: Certain NT2000iX RF generators were serviced using a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stolen McGRATH MAC Video Laryngoscopes
The Issue: Defective video laryngoscopes that did not pass quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 &
The Issue: Poor image quality due to fluid ingress in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXALT Model D Single-Use Duodenoscope
The Issue: Poor image quality due to fluid ingress in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The
The Issue: Due to a software anomaly which potentially could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6
The Issue: The JRNY II BCS XLPE ART ISRT SZ
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II BCS ARTICULAR INSERT
The Issue: The JRNY II BCS XLPE ART ISRT SZ
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPOINT 500 Blood Gas System
The Issue: There are potential drug interferences from Perhexiline Maleate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENTIERO Screening2
The Issue: Affected lots of product may experience technical distortions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENTIERO
The Issue: Affected lots of product may experience technical distortions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENTIERO SCREENING
The Issue: Affected lots of product may experience technical distortions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPOINT 500e Blood Gas System
The Issue: There are potential drug interferences from Perhexiline Maleate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AuDX PRO
The Issue: Affected lots of product may experience technical distortions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV
The Issue: Devices may leak as a result of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERASPHERE ADMIN SET
The Issue: Devices may leak as a result of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30 ML 2PORT BURETTE ASSEMBLY
The Issue: Devices may leak as a result of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO ADMINISTRATION SET
The Issue: Devices may leak as a result of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis ANGIOGRAPHIC CATHETERIZATION SETS
The Issue: Non-sterile product labeled as sterile was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30ML BURETTE ASSY WITH STOPCOCK
The Issue: Devices may leak as a result of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALLERGAN UNIVERSAL FILL KIT
The Issue: Devices may leak as a result of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.