Lower riskMedical device recall · FDA · Published May 6, 2025
HardyCHROM CRE Culture Media Recall: Klebsiella Pneumoniae Breakthrough Risk
Hardy Diagnostics recalls specific lots of HardyCHROM CRE culture media due to Klebsiella pneumoniae growth in some batches. Affected lots were manufactured in March and April 2025 and expire by May 2025. Consumers should check product labels for lot numbers.
“HardyCHROM CRE Culture Media Recall: Klebsiella Pneumoniae Breakthrough Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52339-hardychrom-cre-culture-media-recall-klebsiella-pneumoniae-breakthrough-risk. Based on FDA recall #Z-2041-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2025%22&limit=1).
The FDA announced on May 6, 2025, that Hardy Diagnostics is recalling HardyCHROM CRE culture medium due to quality control failures. The recalled lots exhibited breakthrough growth of Klebsiella pneumoniae.
How to tell if you have it
Brand: Hardy Diagnostics
Product: HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing
Catalog No.: G323
Lot 653594P: Manufactured March 6, 2025; Expires May 15, 2025
Lot 655101P: Manufactured April 4, 2025; Expires June 13, 2025
Lot 656816P: Manufactured April 16, 2025; Expires June 25, 2025
The hazard
According to the FDA, identified lots failed incoming quality control testing. The lots exhibited breakthrough growth of Klebsiella pneumoniae.
Context
GovInfoNow's records show Hardy Diagnostics has 6 other recalls on record since November 14, 2019. Other recent recalls of similar products include Medline Convenience Kits Recall (June 12, 2026), Remel Campy CVA Medium 100/PK recall (February 5, 2026), and Medline Blood Culture Kit Recall (December 24, 2025).
How to tell if you have this one
Check the product label for the lot number (653594P, 655101P, or 656816P) and the expiration date (May 2025 or later). The product was manufactured between March and April 2025.
Brand
Hardy Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot number on the label: 653594P, 655101P, or 656816P.
Where it went and when
Where it was distributed
Distributed in 21 states and Puerto Rico.
Listed by the agency
Not listed
FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Georgia, Illinois, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New York, North Carolina, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2041-2025 (May 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2041-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.