Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- 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
- GET TESTED INTERNATIONAL AB
- Product type
- Diagnostic test kit
- Model numbers
- EAN: 7340221709195, SKU: UGS, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
About This Product
GI Microbiome Profile Small is described as a diagnostic device intended to analyze gut microbiome composition. Consumers could use it to gain insights into intestinal health.
Why This Is Dangerous
The recall centers on distribution without premarket approval or clearance. This regulatory oversight issue could affect safety and efficacy disclosures for patients and clinicians.
Industry Context
This recall is not presented as part of a broader industry pattern in the provided data.
Real-World Impact
The immediate practical impact is regulatory risk for patients and clinicians and potential loss of confidence in a diagnostic product. There is no reported injuries yet.
Practical Guidance
How to identify if yours is affected
- Verify model numbers: EAN 7340221709195 and SKU UGS
- Confirm Lot/Serial Number: All Lots
- Cross-check the FDA recall notice Z-0763-2026
Where to find product info
FDA enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0763-2026
What timeline to expect
Refunds or replacements, if offered, typically take 4-6 weeks after recall initiation
If the manufacturer is unresponsive
- File a formal complaint with the FDA
- Reach out to the manufacturer using any provided contact channels
- Document all communications and response times
How to prevent similar issues
- Always verify regulatory approvals before purchasing medical devices (PMAs or 510(k) clearances)
- Check recall databases for updates before using any diagnostic device
- Only purchase medical devices from reputable sources with clear regulatory disclosures
Documentation advice
Keep the recall notice, packaging, model numbers, serial numbers, and all correspondence with the manufacturer for records
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Product Details
Model numbers: EAN 7340221709195; SKU UGS; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Sold date: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: EAN 7340221709195; SKU UGS
- UDI-DI: None; Lot/Serial Number: All Lots
- Nationwide distribution in the U.S.
- Recall number Z-0763-2026
- Hazard: distribution without premarket approval/clearance
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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