Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012 — Class I medical device recall Z-0076-2023
Ongoing recall by TELEFLEX LLC, reported 2022-10-26, distributed nationwide. Incidents of device splitting or detaching during use
| Recall number | Z-0076-2023 |
|---|---|
| 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 | 42 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04026704347995, 04026704400423 |
| Model numbers | 19012, 19012T |
Product
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
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-0076-2023. 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.