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
- Microbiological Testing Kit
- Model numbers
- UDI-DI: 30845357006463, Lot Numbers: 325-120-1, 325-120-4, 325-120-6, Additional Lots added 12/22/25: 325-119-2
- 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 6-Pack is used for microbiological testing in clinical settings. It is designed to recover specific microorganisms for diagnostic purposes.
Why This Is Dangerous
The hazard arises when the kits fail to recover the target microorganism, potentially leading to misdiagnosis or inappropriate treatment. This can affect patient care in medical environments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face delays in obtaining accurate test results, impacting diagnosis and treatment plans.
Practical Guidance
How to identify if yours is affected
- Check the catalog number: 0325K
- Look for UDI-DI: 30845357006463 on packaging
Where to find product info
Serial numbers and lot numbers are typically located on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks after contacting Microbiologics.
If the manufacturer is unresponsive
- Document all correspondence with Microbiologics.
- Consider reaching out again via phone or email.
- Consult regulatory bodies if necessary.
How to prevent similar issues
- Consider certified microbiological testing kits in the future.
- Check for FDA approval or clearance when purchasing medical devices.
- Review product recalls regularly for safety updates.
Documentation advice
Keep receipts, correspondence with the manufacturer, and photos of the product as a record of the recall.
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Product Details
The recalled product is the KWIK-STIK 6-Pack, Catalog Number 0325K, with UDI-DI: 30845357006463. It includes Lot Numbers: 325-120-1, 325-120-4, 325-120-6, and an additional lot added on 12/22/25: 325-119-2. These were distributed worldwide, including throughout the U.S.
Key Facts
- Recall date: December 2, 2025
- Affected microorganism: Campylobacter jejuni
- Class II recall
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Safety Guide
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