Stop using now Medical device recall · FDA · Published September 4, 2020

AB ULAX 1500 Flex HME Recall: Risk of Disconnection During Use

AB ULAX recalls 1500 Flex Heat and Moisture Exchangers due to risk of disconnection during use, potentially causing lack of oxygen and hypoxia. Affected units have specific catalog references and production dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0059-2021Medical device AB ULAX ›

Stop using this now

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.

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Contact the company

Recalling firmAB ULAXMerkuriusgatan 8 · Motala, Sweden

✎ GovInfoNow plain-language explainer

AB ULAX is recalling 1500 Flex Heat and Moisture Exchangers after reports of them disconnecting from ventilator circuits during use. This could lead to inadequate oxygen delivery, causing hypoxia or death in patients. Read more at govinfonow.com/recall/64378-ab-ulax-1500-flex-hme-recall-risk-of-disconnection-during.

Source Summary by GovInfoNow · govinfonow.com/recall/64378-ab-ulax-1500-flex-hme-recall-risk-of-disconnection-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0059-2021

Cite this page

“AB ULAX 1500 Flex HME Recall: Risk of Disconnection During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64378-ab-ulax-1500-flex-hme-recall-risk-of-disconnection-during. Based on FDA recall #Z-0059-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0059-2021%22&limit=1).

AB ULAX recalled 1500 Flex Heat and Moisture Exchangers due to disconnection hazards that may cause hypoxia or death, according to the FDA on September 4, 2020.

How to tell if you have it

Brand: AB ULAX
Product: 1500 Flex Heat and Moisture Exchanger
Catalog Reference: 150
SAP 109381602, Lots: 2018-09-25 2018-11-20 2018-12-10 2018-12-20 2019-01-03 2019-02-20 2019-03-20 2019-04-15 2019-05-30 2019-06-25 2019-08- 15 2019-09-05 2019- 11-05 2019-11-25
SAP 109381603, Lots 2019-12-20 2020-04-30 2020-05-15 2020-05-20 2020-06-15 2020-06-30
Units affected: 1,484,100

The hazard

The firm received six complaints that the Heat Moisture Exchanger 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.

Context

GovInfoNow's records show other recent recalls of similar products include Baxter Blue Ventilator Adapter Module Recall (2026-02-18), Ventec V+Pro Ventilator Recall (2026-03-25), and Hillrom VOLARA System P.CIRCUIT 5KIT AC Recall (2026-05-21).

How to tell if you have this one

Check for catalog reference 1500 Flex Heat and Moisture Exchangers with specific production dates listed in the recall notice. Affected units have production dates from September 2018 to November 2020.

Brand
AB ULAX
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the affected 1500 Flex Heat and Moisture Exchanger if it disconnects during use.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Sep 4, 2020Firm started the recall
Oct 6, 2020FDA classified it Class II
Oct 14, 2020Published in FDA’s Enforcement Report
Feb 10, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More AB ULAX recalls

Link to this recall

<a href="https://govinfonow.com/recall/64378-ab-ulax-1500-flex-hme-recall-risk-of-disconnection-during">AB ULAX 1500 Flex HME Recall: Risk of Disconnection During Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0059-2021 (September 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0059-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.