Endotracheal Tube labeled as the following: a — Class II medical device recall Z-1011-2023
Ongoing recall by TELEFLEX LLC, reported 2023-02-01, distributed nationwide. Potential for pilot balloon non-inflation or cuff non-deflation.
| Recall number | Z-1011-2023 |
|---|---|
| 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 | 39,690 units |
| UPC / GTIN / UDI-DI | 04026704547579, 04026704547593, 04026704547630, 04026704547647, 04026704547654, 14026704341389, 14026704341396, 14026704341402, 14026704341419, 14026704341426, 14026704341433, 14026704341440, 14026704341457, 14026704341471, 14026704629142, 14026704629159, 14026704629166, 14026704629173, 14026704629180, 14026704629203, 14026704629210 |
| Lot numbers | 112082050, 112082055, 112082060, 112082065, 112082070, 112082075, 112082080, 112082085, 112082095, 112482065LA, 112482070LA, 112482075LA, 112482080LA, 112482085LA, 112482095LA, 112482100LA, 504550, 504560, 504580, 504585, 504590, KME21D1580, KME21D1652, KME21D1653, KME21D1667, KME21D1705, KME21D1706, KME21D1780, KME21D1784, KME21D1878, KME21D1923, KME21D1946, KME21D1956, KME21D1964, KME21D2011, KME21D2012, KME21D2014, KME21D2018, KME21D2020, KME21D2262 and 65 more |
Product
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super 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-1011-2023. 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.