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 33981–34000 of 38,428 recalls
Recalled Item: 00434811113
The Issue: This single manufacturing lot has the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T:slim Insulin Delivery System Insulin Infusion Pump
The Issue: Specific lots of insulin cartridges that are used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa Flu A/B & RSV Direct assay
The Issue: Focus Diagnostics is initiating an urgent safety notice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products White Slides
The Issue: An incorrect assay value (0.3785) was printed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port
The Issue: Reports of wound fluid and /or blood that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew RENASYS Soft Port (The RENASYS
The Issue: Reports of wound fluid and /or blood that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794
The Issue: Reports of wound fluid and /or blood that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew RENASYS-G Sterile
The Issue: Reports of wound fluid and /or blood that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933
The Issue: Reports of wound fluid and /or blood that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew RENASYS-F XL with Soft Port REF #:
The Issue: Reports of wound fluid and /or blood that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Restoris Multicompartmental Knee (MCK) System is an implant system designed
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic
The Issue: Medtronic, Inc. initiated a recall of Medtronic Mosaic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 115 V Blanketrol II
The Issue: The incorrect voltage component was placed into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH Cutting bur
The Issue: Anspach product code L-3SD contained product code S-3SD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panaroma Central Station Product Usage: This device can view real time
The Issue: Mindray has identified two issues with the Panorama
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS
The Issue: Janssen Diagnostics, LLC received complaints of camera failures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection
The Issue: Complaints were received reporting leakage on certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX RIS QDOC 5.8
The Issue: Patient name displayed (printed) on the Patient Report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.5mm Locking Cortical Bone Screw
The Issue: OrthoPediatrics has initiated a Voluntary RECALL of Part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill Template and the Saw Guide for the Ulna Osteotomy
The Issue: The Drill Template and the Saw Guide for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.