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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Biofill Infiltration Cannulas Recalled for Defective Spray Nozzle

Agency Publication Date: February 28, 2025
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Summary

HUMAN MED AG is recalling 775 Biofill Infiltration Cannulas because the nozzle may produce a concentrated spot jet of water instead of the required fan-shaped spray. This recall involves sterile, single-use cannulas with a 2.5mm diameter and 15cm length (REF 2024-012 and 1580107) sold in Florida. No injuries have been reported at this time, but the manufacturer is voluntarily retrieving the affected units.

Risk

A defective nozzle that sprays a concentrated stream instead of a fan spray can cause improper infiltration and potentially lead to unintended tissue trauma during medical procedures.

What You Should Do

  1. This recall affects human med Biofill Infiltration Cannulas (diameter 2.5mm, 15cm) with REF 2024-012 or 1580107, specifically lot numbers 24-20198 and 23-19612.
  2. Stop using the recalled devices immediately and sequester them to ensure they are not used in medical procedures.
  3. Contact the manufacturer, HUMAN MED AG, or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: human med Biofill Infiltration Cannula (diameter 2.5mm, 15cm)
Variants: Diameter 2.5mm, 15cm, Sterile, Single use
Model / REF:
2024-012
1580107
Lot Numbers:
24-20198
23-19612
UDI:
04260170881014

Recall #: Z-1251-2025; Quantity: 775 devices

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96137
Status: Active
Manufacturer: HUMAN MED AG
Sold By: authorized medical distributors
Manufactured In: Germany
Units Affected: 775 devices
Distributed To: Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.