FDA Device recall Z-1251-2025
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use
- FDA Device
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use by Human Med Ag, citing 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 spra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1251-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-18 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Human Med Ag |
| Distribution | US |
Product
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
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.
Identifiers
| code_info | Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2025%22
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