Brand
Covidien LLC
2 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 IIHealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intend
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.
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