Z-1251-2025Class II

human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use

Name: Z-1251-2025 human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use
Creator: Human Med Ag
Published: 2024-10-18
License: https://open.fda.gov/license/

Human Med AG / initiated 2024-10-18 / Open, Classified / root cause: manufacturing process

FDA source

HUMAN MED AG began a recall of human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use on 2024-10-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1251-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-18
Posted: 2025-02-28
Recalling firm: Human Med AG
Product: human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Product code: QPB System, Suction, Lipoplasty For Removal
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 775 devices
Distribution: US Nationwide distribution in the state of FL.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1251-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1251-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-02-28

Product code QPB

K082025Class IIBody-JetHuman Med AG / cleared 2008-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)