HardyDisk AST Cefiderocol 30¿g recall (Hardy Diagnostics)
Medical deviceClass IIOngoing
Summary: Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotr. Reason: 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.
What is being recalled
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN. (states named: Arizona, California, Florida, Idaho, Indiana, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee)
How to tell if yours is affected
Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2887-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 8, 2026 |
| Reported | August 12, 2026 |
| Company | Hardy Diagnostics |
| Company location | Santa Maria, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 43 units |
More recalls from Hardy Diagnostics · all medical device recalls · recalls from June 2026