FDA Medical devices recall ·
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL… recall
- Recall number
- Z-1658-2025
- Date
- (initiated October 2, 2023)
- Company / brand
- Edge Biologicals Inc
598 N 2nd St, Memphis, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 660 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
Why was it recalled?
Due to product outer packaging incorrectly labeled.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
Distribution
U.S. Nationwide distribution in the state of PA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1658-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.