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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/Diagnostic Equipment

Edge Biologicals Sterile Water Recalled for Mislabeled Packaging

Agency Publication Date: April 23, 2025
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Summary

Edge Biologicals Inc is recalling approximately 660 units of Edge Biologicals Sterile Water (3mL, 100/PK) because the outer packaging was incorrectly labeled. This product is used in laboratories to dilute samples and transport media in preparation for microbial testing. No incidents or injuries have been reported regarding this mislabeling.

Risk

Incorrect labeling on the outer packaging could lead to improper identification or use of the sterile water during diagnostic procedures. This error may potentially affect the accuracy or process of microbial testing.

What You Should Do

  1. This recall involves Edge Biologicals Sterile Water (3mL, 100/PK) with catalog number T-0780, lot number 01223, and UDI-DI code B645T-07803012232023012320240123100E.
  2. Stop using the recalled product immediately.
  3. Contact Edge Biologicals Inc or your distributor to arrange for a return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

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

Affected Products

Product: Edge Biologicals Sterile Water (3mL, 100/PK)
Variants: 3mL, 100/PK
Model / REF:
T-0780
Lot Numbers:
01223
UDI:
B645T-07803012232023012320240123100E

Used for diluting sterile reagents and microorganism preparations.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96497
Status: Active
Manufacturer: Edge Biologicals Inc
Sold By: laboratory distributors
Manufactured In: United States
Units Affected: 660 units
Distributed To: Pennsylvania

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.