Data Foundry

Medical device recalls 2023

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set — Class I medical device recall Z-1854-2023

Ongoing recall by TELEFLEX LLC, reported 2023-07-05, distributed nationwide. Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Recall numberZ-1854-2023
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmTELEFLEX LLC, Morrisville, NC, United States
Recall initiated2023-05-25
Classified2023-06-29
Reported by FDA2023-07-05
DistributedNationwide (US)
Quantity17,551 units
UPC / GTIN / UDI-DI04026704547661
Lot numbers18FG05, 18FG13, 18GG17, 18GG28, 18HG16, 18HG25, 18HG29, 18HG35, 18HG38, 18IG06, 18IG12, 18IG24, 18IG27, 18JG11, 18JG14, 18JG26, 18JG34, 18KG23, 18LG05, 18LG12, 18LG22, 19AG18, 19AG21, 19AG37, 19CT32, 19CT55, 19ET45, 19GT05, 19GT20, 19GT38, 19GT59, 19HT05, 19HT15, 19HT40, 19HT80, 19IT29, 19KT08, 19KT25, 19KT41, 19KT48 and 39 more
Model numbers506525

Product

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1854-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.