(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex… — Class II medical device recall Z-1127-2022
Ongoing recall by TELEFLEX MEDICAL INC, reported 2022-06-01, distributed nationwide. Reports received of torn corrugated breathing tubes.
| Recall number | Z-1127-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX MEDICAL INC, Morrisville, NC, United States |
| Recall initiated | 2022-04-11 |
| Classified | 2022-05-24 |
| Reported by FDA | 2022-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CZ, DE, ES, FI, FR, GR, HK, HU, KR, MY, NL, PA, PL, SK |
| Quantity | 290,809 eaches |
| UPC / GTIN / UDI-DI | 04026704388769, 04026704388783, 04026704388790, 04026704388851 |
Product
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
Reason for recall
Reports received of torn corrugated breathing tubes.
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-1127-2022. 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.