FDA recall, , Moderate risk
HardyDisk AST Cefiderocol 30µg (FDC30)
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
Summary by Recall Canary from the FDA notice
What happened
Hardy Diagnostics, located in Santa Maria, California, is recalling 43 units of HardyDisk AST Cefiderocol 30µg (FDC30) REF Z9435, a product used for in vitro agar diffusion susceptibility testing of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex, and Stenotrophomonas maltophilia to Cefiderocol.
The recall was initiated on June 8, 2026, due to incorrect cartridges included in affected products, which may lead to false-susceptible or false-resistant susceptibility results, potentially causing selection of ineffective antimicrobial therapy, delayed treatment, prolonged infection, or worsening clinical outcome.
The product was distributed nationwide in the states of Arizona, California, Florida, Idaho, Indiana, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, and Tennessee. The FDA added the recall to its Enforcement Report on August 5, 2026, and it was in the weekly enforcement report on August 12, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code matches.
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing
- Lot code
- 543461
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Arizona, California, Florida, Idaho, Indiana, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, and Tennessee.
- Company
- Hardy DiagnosticsSanta Maria, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99226
- Recall number
- Z-2887-2026
- Quantity recalled
- 43 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
