Model No — Class II medical device recall Z-1076-2024
Ongoing recall by Maquet Medical Systems USA, reported 2024-02-21, distributed nationwide. The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconfo
| Recall number | Z-1076-2024 |
|---|---|
| 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 | 2024-01-16 |
| Classified | 2024-02-13 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 04058863076355 |
| Lot numbers | 3000301222, 3000319782, 3000327602, 3000333098, 3000352360, 3000357174 |
| Model numbers | 5050USA, 70106.9077 |
Product
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Reason for recall
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
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-1076-2024. 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.