1500 Flex Heat and Moisture Exchanger — Class II medical device recall Z-0059-2021
Terminated recall by AB ULAX, reported 2020-10-14, distributed nationwide. Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory
| Recall number | Z-0059-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AB ULAX, Motala, N/A, Sweden |
| Recall initiated | 2020-09-04 |
| Classified | 2020-10-06 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2023-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, HK, SE, TW |
| Quantity | 1,484,100 units |
| Lot numbers | 109381603, 11-05, 2019, 2019-08 |
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.
Reason for recall
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.
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-0059-2021. 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.