Edge Biologicals Inc: Medical Device Recall in 2025 - (Recall #: Z-1658-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 2, 2023

Date Posted: April 30, 2025

Recall Number: Z-1658-2025

Event ID: 96497

Reason for Recall:

Due to product outer packaging incorrectly labeled.

Status: Ongoing

Product Quantity: 660 units

Code Information:

Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated