Class II — AB ULAX
| Recalling firm | AB ULAX |
|---|---|
| Registered facility | AB ULAX (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to hypoxia or death. |
| Product | 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia. |
| Quantity | 1,484,100 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain. |
| Initiated | 2020-09-04 |
| Classified | 2020-10-06 |
| Terminated | 2023-02-10 |
| Recall number | Z-0059-2021 |
| 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 — AB ULAX (Z-0059-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86417/
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