GET TESTED INTERNATIONAL AB recalled a single Sperm Test device distributed nationwide in the United States on 2025-11-03 due to distribution without FDA premarket approval or clearance. The device was not cleared for sale in the U.S. The company classified the recall as active. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall guidance
Distribution without premarket approval/clearance.
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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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.
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.
This recall is not part of a broader industry pattern.
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.
Information is available on the FDA enforcement page for recall Z-0757-2026 and the manufacturer notice.
Timeline for resolution not specified by the manufacturer.
Keep the recall notice, any correspondence with the manufacturer, receipts, and product packaging.
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.
No injuries or incidents have been reported.
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