# FDA recall Z-1658-2025

> **Edge Biologicals Inc** · Class II · device recall initiated 2023-10-02.

## 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

- **Recall number:** Z-1658-2025
- **Recalling firm:** Edge Biologicals Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-02
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1658-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1658-2025. Source: US FDA. Licensed CC0.

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