Bioseal Trachea Extender 1/pl 50pk/Cs — Class II medical device recall Z-2795-2020
Terminated recall by Bioseal Corporation, reported 2020-08-19, distributed nationwide. The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leaka
| Recall number | Z-2795-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bioseal Corporation, Placentia, CA, United States |
| Recall initiated | 2019-08-15 |
| Classified | 2020-08-13 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2021-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 900 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00630094916019 |
| Lot numbers | 400453, 400456, 400461, 400472, 400476 |
| Model numbers | TRAX01/50 |
Product
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
Reason for recall
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
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-2795-2020. 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.