Hardy Diagnostics recalls
Every recall we track for Hardy Diagnostics — 7 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Hardy Diagnostics peaked in 2020 (3); 7 since 2017.
All FDA recall records for Hardy Diagnostics since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 3 | 0 | 3 |
| 2021 | 0 | 0 | 0 | 1 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Hardy Diagnostics product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Hardy Diagnostics recalls
7 shown- Lower riskMedical device
Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion
Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30μg FDC30 (REF Z9435) for false susceptibility results in antibiotic testing, potentially causing ineffective treatment. Affected units may lead to delayed treatment or worsened infections.
Hardy DiagnosticsJun 8, 2026 - Lower riskMedical device
Hardy Diagnostics recalls HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.
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.
Hardy DiagnosticsMay 6, 2025 - UnratedMedical device
Hardy Diagnostics recalls Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Hardy Diagnostics recalls Quickslide GramPro 1 microscope slide stainers with specific lot and serial numbers due to defective tubing in the pump mechanism.
Hardy DiagnosticsApr 16, 2021 - Lower riskMedical device
Hardy Diagnostics recalls Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires:
Hardy Diagnostics recalls Brain Heart Infusion Agar with 6 ug/ml Vancomycin (Lot 472698) due to Staphylococcus aureus breakthrough. Affected users should check their lot numbers and contact the company for details.
Hardy DiagnosticsDec 21, 2020 - Lower riskMedical device
Hardy Diagnostics recalls Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is
Hardy Diagnostics recalls Viral Transport Medium tubes due to potential contamination that could compromise COVID-19 test results. Affected lots include specific expiration dates and product codes.
Hardy DiagnosticsOct 23, 2020 - Lower riskMedical device
Hardy Diagnostics recalls Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Hardy Diagnostics recalls Strep B Carrot Broth One-Step (Ref. Z40) due to incorrect expiration date on culture medium packaging. The label shows 2021-11-10 instead of the correct 2020-11-10. Consumers should check their product's expiration date and contact Hardy Diagnostics for details.
Hardy DiagnosticsOct 6, 2020 - Lower riskMedical device
Hardy Diagnostics recalls HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct
Hardy Diagnostics recalls HardyCHROM MRSA G307 lot 447694 due to false positive results from MSSA breakthrough. This medium may misidentify MRSA in nasal tests.
Hardy DiagnosticsNov 14, 2019
Hardy Diagnostics recall questions
How many recalls has Hardy Diagnostics had?
7 recalls from Hardy Diagnostics are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Hardy Diagnostics recall?
Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion, dated Jun 8, 2026. Every Hardy Diagnostics recall is listed on this page, newest first.
What should I do if I have a recalled Hardy Diagnostics product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Hardy Diagnostics recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.