Covidien, LLC
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Covidien, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-18FDA-DeviceClass IICheck your Vital Sync monitoring system for alarm issues
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
- 2024-06-19FDA-DeviceClass IIEsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
- 2023-08-09FDA-DeviceClass IICovidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.
- 2023-07-05FDA-DeviceClass IIMedtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.
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