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
- Heavy metals testing device
- Model numbers
- EAN: 616612785749, SKU: 1SM, 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
Heavy Metals Test is a diagnostic device claimed to test for heavy metal presence. It is distributed nationwide in the US.
Why This Is Dangerous
The device was distributed without FDA premarket approval or clearance, creating regulatory noncompliance and potential safety concerns.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
No injuries reported. The recall reflects regulatory risk rather than an established product hazard with reported harm.
Practical Guidance
How to identify if yours is affected
- Verify model number EAN 616612785749 or SKU 1SM
- Confirm lot/serial number: All Lots
- Check distributor and recall number Z-0809-2026
Where to find product info
Refer to the FDA recall page linked in the notice for official identifiers and instructions
What timeline to expect
Remedies will be provided by the manufacturer per their recall instructions. No fixed refund/replacement window is stated in the notice.
If the manufacturer is unresponsive
- File a consumer complaint with the FDA if the manufacturer is unresponsive
- Document all attempts to contact the company and any remedies offered
How to prevent similar issues
- Verify premarket approval status before procuring medical devices
- Check for FDA recall notices on the FDA database
- Avoid distributing devices without proper clearance in your practice
Documentation advice
Keep the recall notice, all communications with the manufacturer, and any responses for records
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Heavy Metals Test Model numbers: EAN 616612785749, SKU 1SM UDI-DI: None Lot/Serial Number: All Lots Sold: US nationwide distribution Recall date: 2025-11-03 Recall number: Z-0809-2026 Status: ACTIVE Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recall number Z-0809-2026
- Model numbers: EAN 616612785749; SKU 1SM
- All Lots affected
- US nationwide distribution
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Safety Guide
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