HardyCHROM CRE — Class II medical device recall Z-2041-2025
Ongoing recall by Hardy Diagnostics, reported 2025-07-09, distributed in AZ, CA, CO, FL, GA, IL, MD, ME…. Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneu
| Recall number | Z-2041-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2025-05-06 |
| Classified | 2025-06-27 |
| Reported by FDA | 2025-07-09 |
| Distributed | AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI, WV |
| Quantity | 4,300 units |
| Lot numbers | 653594P, 655101P, 656816P |
| Model numbers | G323 |
| Expiration dates | 2025-05-15, 2025-06-13, 2025-06-25 |
Product
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Reason for recall
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2041-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.