FDA recall Z-1658-2025

Edge Biologicals Inc · Class II · device

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.

Distribution

U.S. Nationwide distribution in the state of PA.

Key facts

Status
Ongoing
Initiation date
2023-10-02
Report date
2025-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1658-2025