CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report

Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics

Microbiologics is recalling Lyfo Disk, Campylobacter jejuni subsp, distributed nationwide in the US. The recall was initiated on 2 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6

Quantity recalled1 unit (16 additional units added 12/22/25)

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-0986-2026
FDA event ID: 98079
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Ongoing
Recall initiated: 2 Dec 2025
FDA classified: 22 Dec 2025
Reported: 31 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Bacterial Contamination
Device type: Other Medical Devices

Timeline

2 Dec 2025	Recall initiated by company
22 Dec 2025	Classified by FDA	+20 days
31 Dec 2025	Published in enforcement report	+9 days

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

Reason for recall

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Product as listed by the FDA

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

Where it was distributed

Worldwide - US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Which lots are affected?

UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6

Where was it sold?

Worldwide - US Nationwide.

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 98079

This product is part of a recall event; the main page for the event is Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics.

Reported	Class	Recall	Company	Reason	Where
31 Dec 2025	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide

More recalls from Microbiologics

All 66

Reported	Class	Recall	Company	Reason	Where
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
10 Dec 2025Device	CLASS II	Kwik-stik, Quality control kit for culture media recalled	Microbiologics	Packaging Defects	MN
6 Aug 2025Device	CLASS II	Lyfo-disk, M. Canis Derived from Atcc 36299, packaged as recalled	Microbiologics	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS II	Lyfo-disk, M. Canis Derived from Atcc 36299, packaged as recalled	Microbiologics	Device Malfunction	Nationwide

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