FDA Medical Device Recalls (openFDA)
HUMAN MED AG: human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
- Recall number
- Z-1251-2025
- Recalling firm
- HUMAN MED AG
- Product
- human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
- Status
- Open, Classified
- Initiated
- 2024-10-18
- Posted
- 2025-02-28
- Terminated
- not on file
- 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.
- 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
- 775 devices
- Distribution
- US Nationwide distribution in the state of FL.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- K082025
- PMA numbers
- not on file
- Product code
- QPB
- Firm FEI
- 3003587189
- Firm city
- Schwerin
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28