HME for Tracheostomized Patients — Class II medical device recall Z-1869-2021
Ongoing recall by Covidien, LP, reported 2021-06-23, distributed nationwide. The company was notified by their supplier of sterilization services for airway products in Italy of potential
| Recall number | Z-1869-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2021-04-29 |
| Classified | 2021-06-16 |
| Reported by FDA | 2021-06-23 |
| Distributed | Nationwide (US) |
| Quantity | 10,890 |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 10884521779372, 20884521779379 |
| Lot numbers | 19F0869FAX, 19F0870FAX, 20G1669FAX, 20G1670FAX, 20H0377FAX |
| Model numbers | 353S13046 |
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.
Reason for recall
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1869-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.