CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report

Para-Pak Zn-PVA/10% Formalin-for the routine collection recalled

Meridian Bioscience is recalling Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, distributed nationwide in the US. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025

Quantity recalled201 Cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0520-2024
FDA event ID: 93350
Recalling firm: Meridian Bioscience, Cincinnati, OH
Classification: Class II
Status: Ongoing
Recall initiated: 19 Oct 2023
FDA classified: 8 Dec 2023
Reported: 20 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

19 Oct 2023	Recall initiated by company
8 Dec 2023	Classified by FDA	+50 days
20 Dec 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Where it was distributed

Nationwide Foreign: Italy

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025

Where was it sold?

Nationwide Foreign: Italy

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 93350

This product is part of a recall event; the main page for the event is Cardinal Health Clean Stool Transportation System recalled.

Reported	Class	Recall	Company	Reason	Where
20 Dec 2023	CLASS II	Cardinal Health Clean Stool Transportation System recalled	Meridian Bioscience	Packaging Defects	Nationwide
20 Dec 2023	CLASS II	Para-Pak Clean Vial-For the collection, transportation recalled	Meridian Bioscience	Foreign Material	Nationwide

More recalls from Meridian Bioscience

All 15

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Device	CLASS II	Revogene C. difficile, in vitro diagnostic assay intended recalled	Meridian Bioscience	Potency & Assay	Nationwide
26 Nov 2025Device	CLASS II	Group B Streptococcus recalled by Meridian Bioscience	Meridian Bioscience	Foreign Material	14 states
26 Nov 2025Device	CLASS II	alethia c. Difficile recalled by Meridian Bioscience	Meridian Bioscience	Foreign Material	14 states
20 Dec 2023Device	CLASS II	Para-Pak Clean Vial-For the collection, transportation recalled	Meridian Bioscience	Foreign Material	Nationwide
20 Dec 2023Device	CLASS II	Cardinal Health Clean Stool Transportation System recalled	Meridian Bioscience	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide