CLASS III Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

Kwik-stik(TM) labeled as containing Actinomyces odontolyticus recalled

Microbiologics is recalling Kwik-stik(TM) labeled as containing Actinomyces odontolyticus, distributed nationwide in the US. The recall was initiated on 2 Mar 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCatalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701

Quantity recalled2 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-0636-2022
FDA event ID: 89412
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class III
Status: Terminated
Recall initiated: 2 Mar 2017
FDA classified: 10 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

2 Mar 2017	Recall initiated by company
10 Feb 2022	Classified by FDA	+1806 days
16 Feb 2022	Published in enforcement report	+6 days

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

Reason for recall

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.

Where it was distributed

International distribution in the countries of Canada and Germany.

Nationwide

Questions about this recall

Is Kwik-stik(TM) labeled as containing Actinomyces odontolyticus recalled?

Yes. Microbiologics recalled Kwik-stik(TM) labeled as containing Actinomyces odontolyticus on 2 Mar 2017. The recall is Class III and its status is Terminated. Recall number Z-0636-2022.

Why was it recalled?

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Which lots are affected?

Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701

Where was it sold?

International distribution in the countries of Canada and Germany.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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