BEQ-HLS 5050 USA — Class II medical device recall Z-1766-2022
Ongoing recall by Maquet Medical Systems USA, reported 2022-09-28, distributed nationwide. The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrie
| Recall number | Z-1766-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2022-07-22 |
| Classified | 2022-09-19 |
| Reported by FDA | 2022-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04058863076355 |
| Lot numbers | 3000192081, 3000193363, 3000196200, 3000208697, 3000216172 |
| Model numbers | 70106.9077 |
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Reason for recall
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
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-1766-2022. 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.