CLASS II Device recall · Reported 27 Apr 2022 · FDA Enforcement Report

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium recalled

Microbiologics is recalling Inactivated macrolide and quinolone-resistant Mycoplasma genitalium, distributed nationwide in the US. The recall was initiated on 24 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990

Quantity recalled1 ea

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-0954-2022
FDA event ID: 89886
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 24 Mar 2022
FDA classified: 19 Apr 2022
Reported: 27 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Mar 2022	Recall initiated by company
19 Apr 2022	Classified by FDA	+26 days
27 Apr 2022	Published in enforcement report	+8 days

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

Reason for recall

QC process was not adequate for the specification range.

Product as listed by the FDA

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium

Where it was distributed

US Nationwide distribution in the state of TX.

Nationwide Texas

Stores named: Walmart

Questions about this recall

Is Inactivated macrolide and quinolone-resistant Mycoplasma genitalium recalled?

Yes. Microbiologics recalled Inactivated macrolide and quinolone-resistant Mycoplasma genitalium on 24 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-0954-2022.

Why was it recalled?

QC process was not adequate for the specification range.

Which lots are affected?

Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990

Where was it sold?

US Nationwide distribution in the state of TX.

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 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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