CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
HardyCHROM CRE, selective and differential culture medium recalled
Hardy Diagnostics is recalling HardyCHROM CRE, selective and differential culture medium for antimicrobial, distributed in 22 states. The recall was initiated on 6 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2041-2025
- FDA event ID
- 96843
- Recalling firm
- Hardy Diagnostics, Santa Maria, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 May 2025
- FDA classified
- 27 Jun 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 May 2025 | Recall initiated by company | |
| 27 Jun 2025 | Classified by FDA | +52 days |
| 9 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Where it was distributed
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.
ArizonaCaliforniaColoradoFloridaGeorgiaIllinoisMarylandMaineMichiganMinnesotaMissouriNorth CarolinaNebraskaNevadaNew YorkPennsylvaniaPuerto RicoTexasUtahVirginia
Questions about this recall
Why was it recalled?
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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