Hardy Diagnostics recalls

Hardy Diagnostics has 20 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 12 Aug 2026. 2 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is packaging defects.

Total recalls20since 2015

Last 12 months1reported

Class I00% of total

Ongoing2latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 1Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 1 0

Severity split

Class I 0 0%Class II 19 95%Class III 1 5%

Why hardy diagnostics is recalled

Product types

Test Kits & Diagnostics1155%
Other Medical Devices945%

By year

202615%
202515%
2021210%
2020315%
2016210%
20151155%

Ongoing hardy diagnostics recalls

2 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	HardyDisk AST Cefiderocol 30¿g (FDC30) recalled by Hardy Diagnostics	Hardy Diagnostics	Lead & Heavy Metals	Nationwide
9 Jul 2025Device	CLASS II	HardyCHROM CRE, selective and differential culture medium recalled	Hardy Diagnostics	Device Malfunction	22 states

All hardy diagnostics recalls, newest first

20 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	HardyDisk AST Cefiderocol 30¿g (FDC30) recalled by Hardy Diagnostics	Hardy Diagnostics	Lead & Heavy Metals	Nationwide
9 Jul 2025Device	CLASS II	HardyCHROM CRE, selective and differential culture medium recalled	Hardy Diagnostics	Device Malfunction	22 states
16 Jun 2021Device	CLASS II	Quickslide GramPro 1 Automated Gram Stanier is a microscope recalled	Hardy Diagnostics	Device Malfunction	Nationwide
3 Feb 2021Device	CLASS II	Brain Heart Infusion Agar with 6 ug/ml Vancomycin recalled	Hardy Diagnostics	Device Malfunction	11 states
30 Dec 2020Device	CLASS II	Viral Transport Medium recalled by Hardy Diagnostics	Hardy Diagnostics	Foreign Material	Nationwide
18 Nov 2020Device	CLASS III	Strep B Carrot Broth One-Step recalled by Hardy Diagnostics	Hardy Diagnostics	Other	21 states
17 Jun 2020Device	CLASS II	HardyCHROM MRSA recalled by Hardy Diagnostics	Hardy Diagnostics	Packaging Defects	13 states
20 Jul 2016Device	CLASS II	QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO recalled	Hardy Diagnostics	Lead & Heavy Metals	13 states
4 May 2016Device	CLASS II	GBS Detect recalled by Hardy Diagnostics	Hardy Diagnostics	Device Malfunction	14 states
30 Dec 2015Device	CLASS II	FB Broth (Fastidious Bacteria Broth) recalled by Hardy Diagnostics	Hardy Diagnostics	Sterility	4 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.