PlainRecalls

Hardy Diagnostics

Compiled from official public sources by the publisher.

20 recalls on record · Latest: Aug 12, 2026

Subscribe to new Hardy Diagnostics recalls (RSS)

Agency notice ledger

Federal filing book Hardy Diagnostics MID-BOOK · SINGLE-AGENCY

#803 of 14,151 · 20 notices · 0.019% archive

  • BOOK 20 notices
  • RANK #803 of 14,151
  • SHARE 0.019% archive
  • AGENCY FDA Devices (20)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 12, 2026
  • PHOTO AbbVie Inc.

Nearest notice-volume peer: AbbVie Inc. (0 notice gap)

Hardy Diagnostics accounts for about 0.019% of the 104,423-notice archive on 20 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Hardy Diagnostics's standing among 14,151 recalling firms

Hardy Diagnostics ranks 803rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Hardy Diagnostics vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

20 803rd of 14151 higher than 13,326 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Hardy Diagnostics in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Hardy Diagnostics holds about 0.019% of archive notices alongside 20 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 12, 2026

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,
FDA Devices Moderate Jul 9, 2025

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
FDA Devices Moderate Jun 16, 2021

Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
FDA Devices Moderate Feb 3, 2021

Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
FDA Devices Moderate Dec 30, 2020

Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
FDA Devices Low Nov 18, 2020

Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
FDA Devices Moderate Jun 17, 2020

HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206
FDA Devices Moderate Jul 20, 2016

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
FDA Devices Moderate May 4, 2016

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
FDA Devices Moderate Dec 30, 2015

FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
FDA Devices Moderate Sep 2, 2015

HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
FDA Devices Moderate Aug 5, 2015

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.
FDA Devices Moderate Aug 5, 2015

Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
FDA Devices Moderate Aug 5, 2015

Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
FDA Devices Moderate Aug 5, 2015

Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.
FDA Devices Moderate Aug 5, 2015

Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
FDA Devices Moderate Aug 5, 2015

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.
FDA Devices Moderate Aug 5, 2015

Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml 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
FDA Devices Moderate Jul 29, 2015

HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
FDA Devices Moderate Apr 22, 2015

Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

Hardy Diagnostics holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (20 here).

AbbVie Inc. 20 Adm - Chicago 20 AvKARE 20 Carolina Infusion 20 Chicago Sweet Connections, Inc. 20

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Carolina Infusion 20 Davol, Inc., Subs. C. R. Bard, Inc. 20 Hamilton Medical, Inc. 20 Icu Medical de Mexico, S.a. de C.v. 20

Frequently Asked Questions

How many federal recall notices name Hardy Diagnostics? ▼
PlainRecalls indexes 20 distinct federal recall events naming Hardy Diagnostics, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Hardy Diagnostics sit among other recalling firms? ▼
Hardy Diagnostics ranks #803 of 14,151 by distinct recall-event count among 14,151 firms in this archive (94th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Hardy Diagnostics's notices? ▼
FDA Devices accounts for 20 of this firm's 20 indexed notices.
What product category dominates Hardy Diagnostics's filing book? ▼
Filings for Hardy Diagnostics span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Hardy Diagnostics: 20 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Hardy Diagnostics; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026