Iso-Gard Filter S — Class I medical device recall Z-0072-2023
Ongoing recall by TELEFLEX LLC, reported 2022-10-26, distributed nationwide. Incidents of device splitting or detaching during use
| Recall number | Z-0072-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX LLC, Morrisville, NC, United States |
| Recall initiated | 2022-08-29 |
| Classified | 2022-10-14 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 60,500 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04026704347995, 04026704348008, 04026704388325, 04026704400478 |
Product
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
Reason for recall
Incidents of device splitting or detaching during use
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-0072-2023. 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.