Class II — Westmed, Inc.
| Recalling firm | WESTMED, INC. |
|---|---|
| Registered facility | WESTMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. |
| Quantity | 16,000 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom |
| Initiated | 2020-11-11 |
| Classified | 2020-12-29 |
| Terminated | 2023-02-07 |
| Recall number | Z-0745-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Westmed, Inc. (Z-0745-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86903/
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