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, 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
- Sperm test device
- Model numbers
- EAN 7340221710221, SKU VAN-SPE, 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
The Sperm Test device is a diagnostic tool intended to assess semen parameters. It is used by patients or healthcare providers as part of fertility analysis.
Why This Is Dangerous
The hazard is regulatory in nature, due to distribution without required premarket approval or clearance. This could indicate the device was not subjected to standard safety and efficacy review.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers with this device should stop using it and await manufacturer guidance. There is no reported injury yet, but the recall carries regulatory risk and potential consumer confusion.
Practical Guidance
How to identify if yours is affected
- Verify model numbers and lot code: EAN 7340221710221; SKU VAN-SPE; Lot all lots.
- Check packaging for recall notice and the manufacturer name GET TESTED INTERNATIONAL AB.
- Confirm purchase details and whether your device matches the recall scope.
Where to find product info
Information is available on the FDA enforcement page for recall Z-0757-2026 and the manufacturer notice.
What timeline to expect
Timeline for resolution not specified by the manufacturer.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- If the company is unresponsive, file a complaint with the FDA.
- Consult your healthcare provider for safe alternatives during the recall period.
How to prevent similar issues
- Verify regulatory clearance status before purchasing medical devices.
- Buy from reputable sources and check for recall alerts.
- Ask clinicians about FDA-cleared devices when appropriate.
Documentation advice
Keep the recall notice, any correspondence with the manufacturer, receipts, and product packaging.
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Product Details
Brand: GET TESTED INTERNATIONAL AB. Product: Sperm Test device. Model numbers: EAN 7340221710221; SKU VAN-SPE. UDI-DI: None. Lot/Serial Number: All Lots. Sold in: United States nationwide. Recall date: 2025-11-03. Status: Active. Quantity: 1 unit. Price: Unknown. Country of origin: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot/Serial Number: All Lots
- Hazard: Distribution without premarket approval/clearance
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Safety Guide
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