Agency classClass IIOur severity:High FDA (Devices)·Z-1869-2021·Announced 2021-06-23

HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations

Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a medical device used in respiratory care for which potential sterilization deviations were identified. While no illnesses or injuries have been reported, inadequate sterilization of a medical breathing device presents a risk of harm to patients, meeting the rubric criterion for High severity.

Plain-English summary

Covidien LP is recalling HME (Heat and Moisture Exchanger) for Tracheostomized Patients, Item Code 353S13046. The product is indicated for single use on anesthetized and respiratory care patients requiring a breathing circuit with ISO standard 15mm or 22mm connectors. A total of 10,890 units are affected by this recall.

The recall was initiated after the company was notified by their sterilization service provider in Italy that potential deviations occurred from validated parameters for ethylene oxide sterilization. Inadequate sterilization of medical devices used in respiratory care could create a risk of microbial contamination and infection.

Affected lot numbers are 19F0869FAX, 19F0870FAX, 20G1669FAX, 20G1670FAX, and 20H0377FAX. The product was distributed worldwide, with U.S. distribution in Delaware, Kentucky, New York, Texas, Virginia, Vermont, and Washington.

Patients and healthcare providers who have received this product should stop using it immediately and contact Covidien LP or their healthcare provider for guidance on replacement units.

The recalled product

Product: HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Manufacturer: Covidien, LP
Category: Medical Device — Respiratory Equipment
Hazard: sterilization-failure
contamination-risk
Affected units: 10,890

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Covidien, LP

See all →

Severe
Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
Severe
Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
High
V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
High
Surgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
High
V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19

Same hazard · sterilization failure