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 15461–15480 of 38,428 recalls
Recalled Item: Lead diagnostic electrocardiograph under the following device names: ELI 10
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replaceable lead set for the Wireless Acquisition Module (WAM)
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T12. Incorporates wireless electrocardiographic technology to achieve the...
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q-Tel. The Q-Tel RMS system is a computer-based cardiac and
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELI PC. The ELI PC Service automatically converts resting ECG
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S4 and patient cable for the S4 Wireless Telemeter with
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H12+ and patient cable for the H12+ Holter Recorders with
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: safeCLINITUBES Blood Sampler
The Issue: The SafeCLINITUBES blood sampler may have insufficient aspiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: safeCLINITUBES Blood Sampler
The Issue: The SafeCLINITUBES blood sampler may have insufficient aspiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: safeCLINITUBES Blood Sampler
The Issue: The SafeCLINITUBES blood sampler may have insufficient aspiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DR. THAMES - LAP CHOLE
The Issue: There may be a slightly protruding rivet on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clip Applier Kit
The Issue: There may be a slightly protruding rivet on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Epix latis GRASPER
The Issue: There may be a slightly protruding rivet on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Epix latis GRASPER
The Issue: There may be a slightly protruding rivet on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge
The Issue: Iincorrectly packaged without the required lidocaine as labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor
The Issue: Space between the device and the packaging permits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temperature Sensing 100% Silicone Foley Catheter
The Issue: Inadequate incoming inspection practices were utilized on thermistor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.