FDA Device recall Z-1859-2023
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
- 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 506550 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-1859-2023 |
| 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 506550
Reason
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Identifiers
| code_info | UDI/DI 4026704547715, Batch Numbers: 18FG01, 18FG05, 18FG13, 18GG17, 18GG31, 18HG12, 18HG19, 18JG21, 18JG32, 18KG41, 1…UDI/DI 4026704547715, Batch Numbers: 18FG01, 18FG05, 18FG13, 18GG17, 18GG31, 18HG12, 18HG19, 18JG21, 18JG32, 18KG41, 18LG18, 18LG28, 19AG21, 19DT25, 19DT33, 19ET54, 19ET77, 19FT24, 19GT59, 19GT65, 19HT24, 19HT61, 19IT29, 19JT42, 19JT49, 19JT57, 19KT25, 20AT14, 20AT25, 20AT44, 20BT05, 20BT27, 20BT37, 20BT51, 20CT05, 20CT12, 20CT36, 20DT09, 20ET56, 20GT06, 20GT38, KME20H1790, KME20J2114, KME20J3032, KME20K1344, KME20L1842, KME20L1843, KME20L2299, KME20M2094, KME20M2483, KME21A2812, KME21B1693, KME21C0020, KME22B1976, KME22H3204 |
|---|
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-1859-2023%22
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