CLASS II ONGOING Device recall · Reported 22 Nov 2023 · FDA Enforcement Report

Lyfo-disk, P recalled by Microbiologics

Microbiologics is recalling Lyfo-disk, P. venetum, distributed nationwide in the US. The recall was initiated on 18 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10845357019186, Lot Numbers: 794-142-1

Quantity recalled3 units

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-0308-2024
FDA event ID: 93267
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Ongoing
Recall initiated: 18 Oct 2023
FDA classified: 15 Nov 2023
Reported: 22 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Oct 2023	Recall initiated by company
15 Nov 2023	Classified by FDA	+28 days
22 Nov 2023	Published in enforcement report	+7 days

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

Reason for recall

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Product as listed by the FDA

LYFO-DISK, P. venetum, Catalog number 0794L

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.

Nationwide

Questions about this recall

Why was it recalled?

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Which lots are affected?

UDI/DI 10845357019186, Lot Numbers: 794-142-1

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.

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

1 other product · FDA event 93267

This product is part of a recall event; the main page for the event is Kwikstik, P. venetum recalled by Microbiologics.

Reported	Class	Recall	Company	Reason	Where
22 Nov 2023	CLASS II	Kwikstik, P. venetum recalled by Microbiologics	Microbiologics	Other	Nationwide

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