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
- Adrenal Test
- Model numbers
- EAN: 7340221708488, SKU: 2O320-1CO, 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 Adrenal Test is designed to assess adrenal health and hormone levels. Patients often use it for monitoring hormonal imbalances or related health conditions.
Why This Is Dangerous
The risk arises from the lack of regulatory approval, which means the device's safety and effectiveness have not been validated. Using such a device could lead to inaccurate health assessments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the Adrenal Test immediately, which may cause inconvenience for those relying on it for health assessments.
Practical Guidance
How to identify if yours is affected
- Check the model number EAN: 7340221708488 or SKU: 2O320-1CO against recall details.
- If you have the device, verify that it was not approved for use.
- Consult your healthcare provider for additional verification.
Where to find product info
Model numbers and SKU can typically be found on the packaging or device label.
What timeline to expect
Expect a refund processing timeline of 4-6 weeks after following the return instructions.
If the manufacturer is unresponsive
- Document your attempts to contact the manufacturer.
- Reach out to your healthcare provider for assistance.
- If issues persist, consider filing a complaint with the FDA.
How to prevent similar issues
- Always verify that medical devices have FDA approval before use.
- Check for recalls or safety alerts for medical devices regularly.
- Consult healthcare providers about the best products for health monitoring.
Documentation advice
Keep all correspondence related to the recall, including letters and records of contact with the manufacturer.
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Product Details
The recall involves the Adrenal Test with EAN: 7340221708488 and SKU: 2O320-1CO. It was distributed nationwide in the U.S.
Key Facts
- Class II recall
- Immediate stop-use advisory
- Follow manufacturer instructions
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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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