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
- Sperm Test
- Model numbers
- EAN: 7340221700444, SKU: A-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 13, 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 is a medical device designed to assist in evaluating male fertility by analyzing sperm parameters. Consumers typically purchase this product for personal use or with the recommendation of healthcare providers to assess fertility issues.
Why This Is Dangerous
The product's lack of premarket approval means it has not been adequately tested for safety and effectiveness. This raises significant concerns about its reliability and the potential risks associated with its use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product immediately, which may cause inconvenience, particularly for individuals seeking fertility insights.
Practical Guidance
How to identify if yours is affected
- Check if the sperm test was purchased from GET TESTED INTERNATIONAL AB.
- Verify the model number: EAN: 7340221700444 or SKU: A-SPE.
- Contact your healthcare provider if unsure about the model.
Where to find product info
Look for the EAN or SKU numbers on the product packaging or user manual.
What timeline to expect
Expect a timeline of 4-6 weeks for possible refund processing following return instructions.
If the manufacturer is unresponsive
- Reach out again to GET TESTED INTERNATIONAL AB or your healthcare provider.
- Document all communications related to the recall.
How to prevent similar issues
- Ensure any medical device has proper FDA approval before purchase.
- Research products thoroughly before use, especially health-related items.
- Consult healthcare providers for recommended brands and products.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
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Product Details
The recalled sperm test includes all lots under the brand GET TESTED INTERNATIONAL AB. It has been distributed nationwide across the United States. Specific model numbers include EAN: 7340221700444 and SKU: A-SPE.
Key Facts
- Distribution without premarket approval
- Stop use immediately
- Contact healthcare provider for instructions
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Safety Guide
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