FDA Device recall Z-1853-2023
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
- FDA Device
- Class I
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class I recall of Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590 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-1853-2023 |
| 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 Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
Reason
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Identifiers
| code_info | UDI/DI 4026704547654, Batch Numbers: 18FG18, 18FG20, 18GG17, 18GT32, 18HG12, 18HG27, 18HG38, 18IG15, 18IG30, 18KG03, 18…UDI/DI 4026704547654, Batch Numbers: 18FG18, 18FG20, 18GG17, 18GT32, 18HG12, 18HG27, 18HG38, 18IG15, 18IG30, 18KG03, 18KG07, 18KG35, 18LG18, 19AG24, 19AG27, 19BG04, 19DT38, 19DT45, 19ET32, 19ET72, 19FT14, 19GT20, 19HT40, 19IT39, 19IT58, 19KT17, 19KT21, 19LT50, 20BG16, 20BT05, 20BT47, 20CT36, 20CT44, KME20H0238, KME20H0239, KME20H0591, KME20J2420, KME21E1114, KME22B1404, KME22B1405, KME22B1755, KME22C0915, KME22C1943, KME22C2372, KME22D1717, KME22D1718, KME22G1443, KME23A2760, KME23C0137 |
|---|
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-1853-2023%22
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