Hardy Diagnostics: Medical Device Recall in 2025 - (Recall #: Z-2041-2025)

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:

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323

Product Classification:

Class II

Date Initiated: May 6, 2025

Date Posted: July 9, 2025

Recall Number: Z-2041-2025

Event ID: 96843

Reason for Recall:

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

Status: Ongoing

Product Quantity: 4300 ea

Code Information:

UDI-DI 008165760257704 G323 lot 653594P: Manufactured on March 6, 2025; Expires on May 15, 2025 G323 lot 655101P: Manufactured on April 4, 2025; Expires on June 13, 2025 G323 lot 656816P: Manufactured on April 16, 2025; Expires on June 25, 2025

Distribution Pattern:

US domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI and WV.

Voluntary or Mandated:

Voluntary: Firm initiated