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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
December 2, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
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
- Check the catalog number on the packaging: 0325P
- 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
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