human med Biofill Infiltration Cannula, diameter 2.5mm… recallZ-1251-2025 · Human Med AG · initiated Oct 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Human Med AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
The recalling firm issued a Field Safety Notice to Distributors dated 10/18/2025 via email explaining the reason for the Field Safety Notice, the potential hazard, and informing the consignee to discontinue delivering the affected products to customers and users and to dispose of the product if still in their warehouse. A Field Safety Notice was enclosed to be issued to the consignee's users and customers who received the affected product from the Distributor. The User and Customer letter dated 10/17/2024 was similar to the Distributor letter except provided instructions to check the spray pattern as instructed in the user manuals prior to using the cannula. If the pattern was not in a flat, fan-shaped pattern, they are not to use the cannula and it should be sorted out and disposed of properly. A confirmation form was enclosed to confirm the cannula has been correctly disposed of and the form was to be sent to the distributor or to the email address provided.
Recall details
- Recall number
- Z-1251-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 18, 2024
- Posted by the FDA
- Feb 28, 2025
- Recalling firm
- Human Med AG
- Quantity
- 775 devices
- Product code
- QPB
- FDA submissions
- K082025
- Distribution
- US Nationwide distribution in the state of FL.
Product description
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Biofill Infiltration Cannula Single-use, Ø=2.5, L=150, 0H, InfiltrationHuman Med AG · System, Suction, Lipoplasty For Removal1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page