HIGH

GET TESTED INTERNATIONAL AB Recalls Sperm Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 33 units of its sperm test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

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

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

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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

  1. Check if the sperm test was purchased from GET TESTED INTERNATIONAL AB.
  2. Verify the model number: EAN: 7340221700444 or SKU: A-SPE.
  3. 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.

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

  • 33 units recalled
  • Distribution without premarket approval
  • Stop use immediately
  • Contact healthcare provider for instructions

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
EAN: 7340221700444
SKU: A-SPE
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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