Babi — Class I medical device recall Z-0020-2020
Terminated recall by Galemed Corporation, reported 2020-01-01, distributed in NC, NV. Reports of pressure relief manifold venting gas below the standard pressure.
| Recall number | Z-0020-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galemed Corporation, I-Lan, Taiwan |
| Recall initiated | 2019-05-30 |
| Classified | 2019-12-20 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2024-05-20 |
| Distributed | NC, NV |
| Quantity | 2,880 |
| UPC / GTIN / UDI-DI | 04710810093562 |
| Lot numbers | 180718, 181204, 190215, 190610 |
| Model numbers | 1030 |
Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Reason for recall
Reports of pressure relief manifold venting gas below the standard pressure.
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-0020-2020. 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.