Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1251-2025 — human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

U.S. FDA — Device Enforcement · Germany · 2024-10-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1251-2025
Date of alert
2024-10-18
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
HUMAN MED AG
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04260170881014
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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