Class I — Galemed Corporation
| Recalling firm | GaleMed Corporation |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Reports of pressure relief manifold venting gas below the standard pressure. |
| Product | Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802 |
| Quantity | 14964 |
| Distribution | US distribution to distributors in the states of: NC and NV. |
| Initiated | 2019-05-30 |
| Classified | 2019-12-20 |
| Terminated | 2024-05-20 |
| Recall number | Z-0022-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Galemed Corporation (Z-0022-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83318/
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