REF 0562 — Class II medical device recall Z-0746-2021
Terminated recall by Westmed, Inc., reported 2021-01-06, distributed nationwide. There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose.
| Recall number | Z-0746-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Westmed, Inc., Tucson, AZ, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2020-12-29 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2023-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, KR |
| Quantity | 6,000 units |
| UPC / GTIN / UDI-DI | 00709078001697 |
| Lot numbers | 090820N30 |
| Model numbers | 0562 |
Product
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Reason for recall
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.
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-0746-2021. 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.