FDA Medical devices recall ·
HardyCHROM CRE, selective and differential culture medium for… recall
- Recall number
- Z-2041-2025
- Date
- (initiated May 6, 2025)
- Company / brand
- Hardy Diagnostics
1430 W McCoy Ln, Santa Maria, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4300 ea
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Why was it recalled?
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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.
States: Arizona California Colorado Florida Georgia Illinois Maryland Maine Michigan Minnesota Missouri North Carolina Nebraska Nevada New York Pennsylvania Puerto Rico Texas Utah Virginia Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2041-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.