human med Biofill Infiltration Cannula — Class II medical device recall Z-1251-2025
Ongoing recall by HUMAN MED AG, reported 2025-03-12, distributed nationwide. The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconfo
| Recall number | Z-1251-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HUMAN MED AG, Schwerin, Germany |
| Recall initiated | 2024-10-18 |
| Classified | 2025-02-28 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 775 devices |
| UPC / GTIN / UDI-DI | 04260170881014 |
| Lot numbers | 23-19612, 24-20198 |
| Model numbers | 1580107, 2024-012 |
Product
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Reason for recall
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.
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-1251-2025. 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.