Hardy Diagnostics Recalls MDR Acinetobacter and Other Media for Lack of Clearance
Hardy Diagnostics is recalling MDR Acinetobacter and other diagnostic media because they lack FDA 510(k) clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly cites 'lack of 510(k) clearance' as the reason, which is a regulatory compliance issue rather than a direct safety hazard like contamination or defect. No injuries or illnesses are reported.
Plain-English summary
Hardy Diagnostics is recalling MDR Acinetobacter, MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth. The recall is due to the lack of FDA 510(k) clearance for these products.
The affected MDR Acinetobacter products are 15x100mm monoplates packaged 10 plates per sleeve, with a total quantity of 650 units (65 packages of 10). The specific lot numbers involved are 15092, 15101, and 15113, and the catalog number is G259. These products are used for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
The products were distributed nationwide in the United States and in Canada. Consumers and healthcare facilities should stop using these products and contact Hardy Diagnostics for further instructions.
The recalled product
- Product
- Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
- Manufacturer
- Hardy Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot number: 15092
- 15101
- 15113 Cat no. G259
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Hardy Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Hardy Diagnostics
See all →- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- SevereHardyCHROM CRE Culture Medium Recalled for Quality Control Failure
FDA (Devices) · 2025-07-09
- ModerateMedical microscope slide stainer recalled due to defective pump tubing
FDA (Devices) · 2021-06-16
- HighHardy Diagnostics Recalls Brain Heart Infusion Agar Plates Due to Contamination
FDA (Devices) · 2021-02-03
- HighHardy Diagnostics Recalls Viral Transport Media Due to Contamination Risk
FDA (Devices) · 2020-12-30
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01