FDA Device recall Z-1858-2023
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
- FDA Device
- Class I
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class I recall of Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545 by Teleflex, citing reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1858-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-25 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
Product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
Reason
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Identifiers
| code_info | UDI/DI 4026704547708, Batch Numbers: 18FG05, 18FG13, 18GG20, 18HG16, 18IG06, 18IG12, 18JG04, 18JG14, 18JG21, 18JG34, 1…UDI/DI 4026704547708, Batch Numbers: 18FG05, 18FG13, 18GG20, 18HG16, 18IG06, 18IG12, 18JG04, 18JG14, 18JG21, 18JG34, 18KG35, 18LG02, 18LG18, 18LG28, 19BG21, 19CT49, 19FT35, 19GT20, 19GT28, 19GT38, 19GT59, 19GT65, 19HT24, 19HT80, 19IT29, 19KT25, 19KT48, 19LT38, 20AT09, 20BG16, 20BT05, 20CT05, 20CT36, 20CT44, 20DT37, 20GG45, KME20H2927, KME20H2928, KME20K2248, KME20L0620, KME20L1471, KME20L1472, KME20L2030, KME20M2482, KME21A1892, KME21A1893, KME21A2811, KME21B0576, KME22G3102, KME22J2956, KME22K2778, KME22L3057, KME23A2083, KME23B1203 |
|---|
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-1858-2023%22
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