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 17261–17280 of 38,428 recalls
Recalled Item: Fukushima suction tubes
The Issue: There was incorrect raw material used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory
The Issue: The Assay may give a false negative result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The
The Issue: Non-conforming devices are identified, which may not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
The Issue: Performance issues with certain lots of the Elecsys
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
The Issue: Performance issues with certain lots of the Elecsys
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm)
The Issue: The firm received a complaint that the connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion systems with software version R1.2 -Interventional...
The Issue: The cold restart of Azurion R1.2 systems may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817
The Issue: Supplier initiated recall of the GRIPPER Needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maintenance Flush Kit/Blood Draw Product Code: DT19335
The Issue: Supplier initiated recall of the GRIPPER Needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit
The Issue: Supplier initiated recall of the GRIPPER Needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Port full Access Tray Product Code: DT19330
The Issue: Supplier initiated recall of the GRIPPER Needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage:
The Issue: Negative Bias with Lot EA9227
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Cogent Hemodynamic Monitoring System
The Issue: Firm identified several software issues through internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom Receiver
The Issue: It has been reported that use of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: This is an in vitro diagnostic product intended for use
The Issue: Randox Laboratories realigned RX Analyser Series calibration targets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maximum Pelvic Trainer (MPT)
The Issue: The device was incorrectly listed with the FDA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number...
The Issue: The sets are configured with quick connectors that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge OrthoPACS versions 7.3
The Issue: for prior thumbnails to not display in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS versions 7.3
The Issue: for prior thumbnails to not display in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Logolas Laser Projection Series
The Issue: The User Remote Interlock Dongle provided with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.