Class II — HUMAN MED AG
| Recalling firm | Human Med AG |
|---|---|
| Registered facility | HUMAN MED AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet. |
| Product | human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use. |
| Quantity | 775 devices |
| Distribution | US Nationwide distribution in the state of FL. |
| Initiated | 2024-10-18 |
| Classified | 2025-02-28 |
| Recall number | Z-1251-2025 |
| 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 II recall — HUMAN MED AG (Z-1251-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96137/
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