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 15301–15320 of 38,428 recalls
Recalled Item: therascreen EGFR RGQ PCR Kit (24)
The Issue: There is a risk for a false mutation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PAC Tray/5 Catheter Introducer Tray 8F
The Issue: Arterial Line Kits include thicker curved reverse-cutting needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arterial Line Kit 20ga X 3"
The Issue: Arterial Line Kits include thicker curved reverse-cutting needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arterial Line Kit 20ga X 3"
The Issue: Arterial Line Kits include thicker curved reverse-cutting needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N
The Issue: In certain firmware versions, in case a Clot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212)
The Issue: In certain firmware versions, in case a Clot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212)
The Issue: for discrepant patient results due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N...
The Issue: The identified problem is an erroneous association between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00
The Issue: The identified problem is an erroneous association between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab Automation System used with the following Modules: High Volume
The Issue: The sensors which activate the safety switches may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerator a3600 Automation System used with the following Modules: High
The Issue: The sensors which activate the safety switches may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00
The Issue: The identified problem is an erroneous association between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit
The Issue: Prismaflex product code 114870 does not have FDA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oryx Cervical Screw Caddy
The Issue: Cervical screw caddies have incorrect text markings for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch
The Issue: small holes at the seam lines of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inpeco FlexLab
The Issue: When analyzer sample carousel lid remains open or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Accelerator a3600
The Issue: When analyzer sample carousel lid remains open or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 -
The Issue: Ambulance Cots may not meet crash test standard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch
The Issue: small holes at the seam lines of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Accelerator a3600 Centrifuge Module tube loading algorithm
The Issue: The FlexLab Centrifuge Module loading algorithm may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.