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 17781–17800 of 38,428 recalls
Recalled Item: Replacement leadwires with grabber ends: REF/Catalog Number Description...
The Issue: ECG trunk cables and leadwires may reduce the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable
The Issue: ECG trunk cables and leadwires may reduce the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replacement ECG leadwires with snap ends REF/Catalog Number Description...
The Issue: ECG trunk cables and leadwires may reduce the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set
The Issue: ECG trunk cables and leadwires may reduce the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioCommand
The Issue: corrosion of the battery contact(s)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emerald Diluent Tubing
The Issue: The diluent tubing used on the instrument appears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rim Plate
The Issue: The titanium implant has the wrong article number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nasal Alar SpO2 Sensor
The Issue: These Instructions for Use has missing instructions related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Step Draco Pad
The Issue: This product has been contaminated with Stenotrophomonas lactiubi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent
The Issue: This product has been contaminated with Stenotrophomonas lactiubi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Infusion Set
The Issue: An incomplete occlusion can be caused by a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RNeasy DSP FFPE Kit (48)
The Issue: The deparaffinization solution contains a contaminant, which leads
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part
The Issue: User may suffer an electric shock when coming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The
The Issue: issue related to the operation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe
The Issue: The firm received one customer complaint concerning three
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Connect Diabetes Management App
The Issue: Users with Android OS 8.0 and above may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Primary Warmer Pack
The Issue: The Vyaire enFlow disposable cartridge was recalled due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Creatine Kinase (CK_L) reagent
The Issue: A steady upward trend in blank (u) absorbance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Creatine Kinase (CK_L) Reagent
The Issue: A steady upward trend in blank (u) absorbance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Medical Technologies EndoTool IV
The Issue: Insulin dosing calculations were erroneously high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.