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 13001–13020 of 38,428 recalls
Recalled Item: ADVIA 2120 SAA AUTOSAMPLER (SMN 10374453) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i Single Aspirate (SMN 11314044) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trial Cutting Guide for Triathlon Total Knee System
The Issue: The posterior condyle of the Specialty Triathlon TS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail
The Issue: The spreader bar can disconnect from the scale
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis/ Sensis Vibe Hemo systems with VD12A software as follows:
The Issue: Due to the configuration of certain Windows Service
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm
The Issue: for the device safety interlock to fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm
The Issue: for the device safety interlock to fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30
The Issue: for the device safety interlock to fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard
The Issue: ROi CPS, LLC has become aware, through a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: p-Chip Wand Reader
The Issue: The laser operation might fall under a higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad
The Issue: Pump Module keypad lifting, and Fluid ingress could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console
The Issue: An electrical component within the system controller module
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information
The Issue: Patient related messages created in RayCare 3B, RayCare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed
The Issue: SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BCS XP System: Multipurpose system for in vitro coagulation studies.
The Issue: Siemens Healthcare Diagnostics Products GmbH has confirmed that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch
The Issue: Due to Products being incorrect labeling "for diagnostic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Consist of a distal connection mechanism (either standard Terumo Ball
The Issue: There is a potential for the stainless steel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS - Radiological Image Processing System - Product Usage:
The Issue: The wrong patient information may be displayed in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated Impella Controller (AIC)
The Issue: Retrospective reporting for the release of Technical Bulletin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.