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Microbiologics Recalls KWIK-STIK Over Testing Failure Risk

Microbiologics recalled 86 units of the KWIK-STIK 2-Pack on December 2, 2025. The affected products may fail to recover the target microorganism Campylobacter jejuni. This recall affects units distributed worldwide, including the U.S.

Official notice
MicrobiologicsHealth & Personal CareMedical DevicesUDI-DI: 20845357006459Lot Numbers: 325-120-3325-120-7

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 2, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 2, 2025
Hazard Level
HIGH
Brand
Microbiologics
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Microbiologics
Product type
Microbial Testing Kit
Model numbers
UDI-DI: 20845357006459, Lot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 2, 2025

  2. Reported by FDA DEVICE

    December 31, 2025

  3. RecallRadar source check

    January 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Microbiologics Inc or your healthcare provider for instructions. Notification method: Letter

About This Product

The KWIK-STIK 2-Pack is a microbial testing kit used in laboratories for detecting specific microorganisms. Consumers, primarily healthcare professionals and laboratories, rely on these kits for accurate testing of pathogens.

Why This Is Dangerous

The recall pertains to a failure in the KWIK-STIK to recover Campylobacter jejuni, which may lead to undetected infections. This issue could compromise patient safety and treatment efficacy.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare providers and patients who depend on accurate microbial testing. Inaccurate results may lead to misdiagnosis or inappropriate treatment.

Practical Guidance

How to identify if yours is affected

  1. Check the catalog number on the packaging: 0325P
  2. Stop using the product immediately if it matches the lot numbers.

Where to find product info

Lot numbers can typically be found on the product packaging or documentation enclosed with the kit.

What timeline to expect

Expect a processing time of 4-6 weeks for any refund or replacement after the return is initiated.

If the manufacturer is unresponsive

  • Document your communications with Microbiologics.
  • File a complaint with the FDA if they do not respond.
  • Consider contacting consumer protection organizations for assistance.

How to prevent similar issues

  • Look for FDA approval or clearance when purchasing medical devices.
  • Check for recalls before using medical devices.
  • Consult with healthcare professionals before using new products.

Documentation advice

Keep records of your purchase, any correspondence with the manufacturer, and photos of the product for your records.

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Product Details

The recall includes the KWIK-STIK 2-Pack, Catalog Number 0325P. Affected lot numbers are 325-120-3, 325-120-7, and additional lots added on December 22, 2025: 325-119-1, 325-119-5. The units are categorized as Class II.

Key Facts

  • Recall date: December 2, 2025
  • Affected quantity: 86 units
  • Class II recall
  • Contact Microbiologics for instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMicrobial Testing Kit
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI-DI: 20845357006459
Lot Numbers: 325-120-3
325-120-7
Additional Lots added 12/22/25: 325-119-1
325-119-5
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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