Edge Biologicals STERILE WATER — Class II medical device recall Z-1658-2025
Ongoing recall by Edge Biologicals Inc, reported 2025-04-30, distributed nationwide. Due to product outer packaging incorrectly labeled.
| Recall number | Z-1658-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edge Biologicals Inc, Memphis, TN, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2025-04-23 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 660 units |
| Reason classes | labeling |
| Lot numbers | 01223 |
| Model numbers | T-0780 |
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
Reason for recall
Due to product outer packaging incorrectly labeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1658-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.