FDA Device recall Z-1011-2023
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal by Teleflex, citing potential for pilot balloon non-inflation or cuff non-deflation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1011-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-08 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
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
Potential for pilot balloon non-inflation or cuff non-deflation.
Identifiers
| code_info | a. Product Code, Batch Number (UDI): 504550, KME21D1964 ((01)4026704547579(17)260328(10)KME21D1964), 504560, KME21E1412…a. Product Code, Batch Number (UDI): 504550, KME21D1964 ((01)4026704547579(17)260328(10)KME21D1964), 504560, KME21E1412 ((01)4026704547593(17)260428(10)KME21E1412), 504580, KME21D1784 ((01)4026704547630(17)260328(10)KME21D1784), 504580, KME21E1286 ((01)4026704547630(17)260428(10)KME21E1286), 504585, KME21E1295 ((01)4026704547647(17)260428(10)KME21E1295), 504590, KME21E1114 ((01)4026704547654(17)260428(10)KME21E1114); b. Product Code, Batch Number (UDI): 112082050, KME21F0727 ((01)14026704341389(17)260528(10)KME21F0727), 112082050, KME21F0321 ((01)14026704341389(17)260528(10)KME21F0321), 112082055, KME21E0864 ((01)14026704341396(17)260428(10)KME21E0864), 112082055, KME21F0946 ((01)14026704341396(17)260528(10)KME21F0946), 112082055, KME21E1230 ((01)14026704341396(17)260428(10)KME21E1230), 112082060, KME21E0660 ((01)14026704341402(17)260428(10)KME21E0660), 112082060, KME21E1391 ((01)14026704341402(17)260428(10)KME21E1391), 112082065, KME21E0607 ((01)14026704341419(17)260428(10)KME21E06 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1011-2023%22
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