CLASS III Device recall · Reported 1 Jun 2022 · FDA Enforcement Report

Kwik-stik" plus: Clostridium perfringens recalled by Microbiologics

Microbiologics is recalling Kwik-stik" plus: Clostridium perfringens, distributed nationwide in the US. The recall was initiated on 6 May 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codescatalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374

Quantity recalled8 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-1125-2022
FDA event ID: 90150
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class III
Status: Terminated
Recall initiated: 6 May 2022
FDA classified: 23 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

6 May 2022	Recall initiated by company
23 May 2022	Classified by FDA	+17 days
1 Jun 2022	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

Labeling error.

Product as listed by the FDA

KWIK-STIK" plus: Clostridium perfringens

Where it was distributed

Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.

Nationwide Iowa Tennessee

Questions about this recall

Why was it recalled?

Labeling error.

Which lots are affected?

catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374

Where was it sold?

Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.

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 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.

More recalls from Microbiologics

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31 Dec 2025Device	CLASS II	Lyfo Disk, 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
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
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