Data Foundry

Medical device recalls 2023

Cardinal Health Clean Stool Transportation System-For the collection — Class II medical device recall Z-0521-2024

Ongoing recall by Meridian Bioscience Inc, reported 2023-12-20, distributed nationwide. Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

Recall numberZ-0521-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMeridian Bioscience Inc, Cincinnati, OH, United States
Recall initiated2023-10-19
Classified2023-12-08
Reported by FDA2023-12-20
DistributedNationwide (US)
Countries outside the USIT
Quantity38 cases
Reason classespackaging
UPC / GTIN / UDI-DI50885380144859
Lot numbers510020Q
Model numbersCHB900312
Expiration dates2030-09-15

Product

Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0521-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.