Endotracheal Tube labeled as the following: a — Class II medical device recall Z-1012-2023
Ongoing recall by TELEFLEX LLC, reported 2023-02-01, distributed nationwide. Potential for pilot balloon non-inflation or cuff non-deflation.
| Recall number | Z-1012-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX LLC, Morrisville, NC, United States |
| Recall initiated | 2022-12-08 |
| Classified | 2023-01-23 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BB, BE, BG, BR, BS, CA, CH, CL, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IS, IT, JO, KR, KW, LB, MA, MX, MY, NL, NO, NP, PA, PH, PL, PT, RS, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, ZA |
| Quantity | 497 units |
| UPC / GTIN / UDI-DI | 14026704195937, 14026704195968, 14026704196019, 14026704196026, 14026704196033, 14026704196040, 14026704196057, 14026704196064, 14026704196071, 14026704196088, 14026704196200, 14026704196217, 14026704196224, 14026704196231, 14026704196248, 14026704196255, 14026704196262, 14026704196279, 14026704196286, 14026704196293, 14026704196330, 14026704196347, 14026704196361, 14026704196378, 14026704196385 and 12 more |
| Lot numbers | 112080-000065, 112080-000080, 112082-000050, 112082-000055, 112082-000060, 112082-000065, 112082-000070, 112082-000075, 112082-000080, 112082-000085, 112480-000050, 112480-000055, 112480-000060, 112480-000065, 112480-000070, 112480-000075, 112480-000080, 112480-000085, 112480-000090, 112480-000095, 112481-000055, 112481-000060, 112481-000070, 112481-000075, 112481-000080, 112481-000085, 112481-000090, 112482-000050, 112482-000055, 112482-000060, 112482-000065, 112482-000070, 112482-000075, 112482-000080, 112482-000085, 112482-000090, 112482-000095, KME21D0707, KME21D1146, KME21D1153 and 460 more |
Product
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
Reason for recall
Potential for pilot balloon non-inflation or cuff non-deflation.
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-1012-2023. 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.