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 34861–34880 of 38,428 recalls
Recalled Item: CareFusion Gravity Set
The Issue: CareFusion is recalling the Gravity Set (Model 44000-07)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Device Name: Terino Square Chin-Style II-Medium
The Issue: Implantech initiated a voluntary recall of certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i Endosseous Dental Implant.
The Issue: Due to residual machining fluid identified by discoloration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN:
The Issue: High positive calcium bias on plasma sample versus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN
The Issue: High positive calcium bias on plasma sample versus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by
The Issue: It was discovered that Carestream received a report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for
The Issue: Updated Instructions for Use: Bloodline connections not tightened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Composite Series Skull Clamp
The Issue: An investigation of an adverse trend of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis
The Issue: Updated Instructions for Use: Bloodline connections not tightened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code:
The Issue: Pillow valve included in the FMS Duo outflow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649
The Issue: Pillow valve included in the FMS Duo outflow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Combiset Blood Line with BVM for Hemodialysis use Catalog Number:
The Issue: Updated Instructions for Use: Bloodline connections not tightened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESTREAM DRX -Mobile Retrofit Kit
The Issue: Carestream Health Inc. has conducted a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX- Revolution
The Issue: Carestream Health Inc. has conducted a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific TELIGEN
The Issue: The performance of a low voltage capacitor in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific COGNIS CRT-D
The Issue: The performance of a low voltage capacitor in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reliance Endoscope Processing System (REPS)
The Issue: The air pipe that delivers unfiltered ambient air
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAD Fluoro Uro System (Ysio
The Issue: When using systems operating with software versions VD10A/G
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: *** 1) SYMBIQ One-Channel Infuser
The Issue: Hospira shipped the incorrect replaceable battery pack (Part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S-LIFT Extension Shims Extension shims are manufactured from grade 5
The Issue: Fit variation among all lots of S-LIFT extension
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.