FDA Device recall Z-1845-2023

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550

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 504550 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-1845-2023
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 504550

Reason

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Identifiers

code_info	UDI/DI 4026704547579, Batch Numbers: 18FG03, 18FG13, 18GG12, 18GG17, 18GG31, 18HG12, 18IG02, 18IG12, 18IG21, 18IG27, 1… UDI/DI 4026704547579, Batch Numbers: 18FG03, 18FG13, 18GG12, 18GG17, 18GG31, 18HG12, 18IG02, 18IG12, 18IG21, 18IG27, 18JG02, 18KG15, 18LG25, 18LG37, 19AG37, 19BG07, 19BG21, 19CT71, 19ET54, 19FT14, 19FT24, 19GT10, 19GT20, 19GT38, 19GT65, 19HT05, 19HT40, 19HT66, 19JT70, 19KT08, 19LT17, 19LT32, 20AT14, 20AT25, 20BT27, 20BT37, 20CT36, 20CT54, 20DT14, 20ET04, 20ET21, 20GT38, KME20H0128, KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21D1964, KME21F1551, KME21G1707, KME21K0545, KME21K1249, KME21M0011, KME21M1831, KME21M2074, KME21M2647, KME22B0171, KME22B0172, KME22B1395, KME22B1632, KME22C0436, KME22C1654, KME22C3003, KME22D0145, KME22D0825, KME22E1129, KME22H0163, KME22H1169, KME22H1703, KME22H1709, KME22J3162, KME22J3163

code_info

UDI/DI 4026704547579, Batch Numbers: 18FG03, 18FG13, 18GG12, 18GG17, 18GG31, 18HG12, 18IG02, 18IG12, 18IG21, 18IG27, 1…

UDI/DI 4026704547579, Batch Numbers: 18FG03, 18FG13, 18GG12, 18GG17, 18GG31, 18HG12, 18IG02, 18IG12, 18IG21, 18IG27, 18JG02, 18KG15, 18LG25, 18LG37, 19AG37, 19BG07, 19BG21, 19CT71, 19ET54, 19FT14, 19FT24, 19GT10, 19GT20, 19GT38, 19GT65, 19HT05, 19HT40, 19HT66, 19JT70, 19KT08, 19LT17, 19LT32, 20AT14, 20AT25, 20BT27, 20BT37, 20CT36, 20CT54, 20DT14, 20ET04, 20ET21, 20GT38, KME20H0128, KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21D1964, KME21F1551, KME21G1707, KME21K0545, KME21K1249, KME21M0011, KME21M1831, KME21M2074, KME21M2647, KME22B0171, KME22B0172, KME22B1395, KME22B1632, KME22C0436, KME22C1654, KME22C3003, KME22D0145, KME22D0825, KME22E1129, KME22H0163, KME22H1169, KME22H1703, KME22H1709, KME22J3162, KME22J3163

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-1845-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.