FDA Device recall Z-1766-2022
BEQ-HLS 5050 USA
- FDA Device
- Class II
- ongoing
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class II recall of BEQ-HLS 5050 USA by Maquet Medical Systems Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1766-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-22 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
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
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).
Identifiers
| code_info | UDI-DI: 04058863076355 Lots 3000192081, 3000193363, 3000196200, 3000208697, 3000216172 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1766-2022%22
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