CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
Biofill Infiltration Cannula, diameter recalled by Human Med Ag
Human MED is recalling Biofill Infiltration Cannula, diameter, distributed nationwide in the US. The recall was initiated on 18 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1251-2025
- FDA event ID
- 96137
- Recalling firm
- Human MED, Schwerin
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Oct 2024
- FDA classified
- 28 Feb 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 18 Oct 2024 | Recall initiated by company | |
| 28 Feb 2025 | Classified by FDA | +133 days |
| 12 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Where it was distributed
US Nationwide distribution in the state of FL.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the state of FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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