Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance
Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a lack of 510(k) clearance, which is a regulatory and documentation issue rather than a direct safety hazard or defect causing injury.
Plain-English summary
Hardy Diagnostics is recalling several diagnostic media products, including VRE Broth, MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, and BEA Broth with Vancomycin. The recall is being conducted because the products lack FDA 510(k) clearance.
The affected products were distributed nationwide in the United States and in Canada. Specific lot numbers for the VRE Broth include 15021, 15043, 15072, 15126, and 15152, with catalog number K103. The quantity involved is 900 units.
Consumers and healthcare facilities should stop using these products and contact Hardy Diagnostics for further instructions or a refund.
The recalled product
- Product
- Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
- 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 (5)
- Lot number: 15021
- 15043
- 15072
- 15126
- 15152 Cat no. K103
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