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Lower risk Medical device recall · FDA · Published October 19, 2023

Meridian Bioscience Clean Stool Transport System Recall: Leakage Risk

Meridian Bioscience recalls certain clean stool transportation systems due to a manufacturing defect that may cause leakage. This affects specific catalog numbers and lot numbers.

🇺🇸 FDA recall #Z-0521-2024Medical deviceMeridian Bioscience ›
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Recalling firmMeridian Bioscience Inc3471 River Hills Dr · Cincinnati, OH 45244-3023
✎ GovInfoNow plain-language explainer

Meridian Bioscience is recalling specific clean stool transportation systems because some vials may leak due to a manufacturing defect. This could lead to contamination or improper sample handling if the vials leak. Read more at govinfonow.com/recall/57035-meridian-bioscience-clean-stool-transport-system-recall-leakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57035-meridian-bioscience-clean-stool-transport-system-recall-leakage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0521-2024

Cite this page

“Meridian Bioscience Clean Stool Transport System Recall: Leakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57035-meridian-bioscience-clean-stool-transport-system-recall-leakage-risk. Based on FDA recall #Z-0521-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0521-2024%22&limit=1).

Meridian Bioscience Inc recalled the Cardinal Health Clean Stool Transportation System due to a manufacturing defect causing Para-Pak vial leakage risk, according to the FDA on Oct. 19, 2023.

How to tell if you have it

  • Brand: Meridian Bioscience
  • Product: Cardinal Health Clean Stool Transportation System
  • Catalog Number: CHB900312
  • UDI-DI: 50885380144859*
  • Lot Numbers: 510020Q
  • Expiration Date: 09/15/2030

The hazard

Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

Context

GovInfoNow's records show Meridian Bioscience Inc has 8 other recalls on record since Dec. 17, 2018. Other recent recalls of similar products include Leaky Gut Test Product Recall (Nov. 3, 2025), Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026) and Boston Scientific Intracept Access Instruments Recall (April 22, 2026).

How to tell if you have this one

Check for the catalog number CHB900312 and lot number 510020Q on the vial packaging. The product was sold from 2023 to 2030 with an expiration date of September 15, 2030.

  • Brand
    Meridian Bioscience
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide Foreign: Italy
Recall numberProduct, codes & lotsQuantity
Z-0519-2024Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312; UDI-DI: 00840733101892 Lot Numbers: 509940Q Expiration Date: 09/12/2030571 Cases
Z-0520-2024Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012; UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025201 Cases
Z-0521-2024Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312; UDI-DI: 50885380144859* *The UDI information for this product is maintained by Cardinal Health. Lot Numbers: 510020Q Expiration Date: 09/15/203038 Cases
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the catalog number CHB900312 and lot number 510020Q on the vial packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide Foreign: Italy” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Oct 19, 202312. FDA classified it Class II: Dec 8, 202323. Published in FDA’s Enforcement Report: Dec 20, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0521-2024 (October 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0521-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA