Para-Pak Zn-PVA/10% Formalin-for the routine collection — Class II medical device recall Z-0520-2024
Ongoing recall by Meridian Bioscience Inc, reported 2023-12-20, distributed nationwide. Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of inc
| Recall number | Z-0520-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-12-08 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Quantity | 201 cases |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840733101250 |
| Lot numbers | 509130Q |
| Model numbers | 301012 |
| Expiration dates | 2025-08-11 |
Product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Reason for recall
Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
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-0520-2024. 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.