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
- GI Microbiome Profile XL
- Model numbers
- EAN: 7340221709225, SKU: UGXL, 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
December 17, 2025
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
The GI Microbiome Profile XL is a medical device intended to analyze gut microbiome composition. Consumers may seek this device for insights into their digestive health and overall wellness.
Why This Is Dangerous
The device poses risks because it was distributed without the required premarket approval, meaning it has not been assessed for safety and effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a limited number of units and is primarily a regulatory issue, but it requires immediate action from consumers who possess the device.
Practical Guidance
How to identify if yours is affected
- Locate the model number EAN: 7340221709225 or SKU: UGXL on the device packaging.
- If you have purchased this device, check for any notification from GET TESTED INTERNATIONAL AB.
- Confirm that your device is within the recalled units by verifying against the quantities listed in the recall.
Where to find product info
Model numbers and information can usually be found on the product packaging or user manual.
What timeline to expect
You can expect a refund or resolution within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all correspondence with GET TESTED INTERNATIONAL AB.
- File a complaint with the FDA if there is no response within a reasonable timeframe.
- Consider seeking legal advice if you experience issues with the recall process.
How to prevent similar issues
- Always check for FDA approval before purchasing medical devices.
- Look for devices with clear labeling on safety and efficacy.
- Be cautious of products marketed without regulatory oversight.
Documentation advice
Keep records of your purchase, including receipts and any communication with the manufacturer.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The GI Microbiome Profile XL has model numbers EAN: 7340221709225, SKU: UGXL. It was distributed nationwide in the U.S. The quantity recalled is three units.
Key Facts
- Recalled product: GI Microbiome Profile XL
- Manufacturer: GET TESTED INTERNATIONAL AB
- Recall date: November 3, 2025
- Total units recalled: 3
- Hazard: Distribution without premarket approval
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.