GET TESTED INTERNATIONAL AB began a recall of Sperm Test on . FDA classified it as Class II and gives the reason as "Distribution without premarket approval/clearance". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0750-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Get Tested International AB
- Product
- Sperm Test
- Product code
- POV Semen Analysis Device
- Reason for recall
- Distribution without premarket approval/clearance.
- FDA root cause
- No Marketing Application
- Action
- On November 3, 2025, MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: If you still have an unused test, it should not be used. You should render the kit unusable and discard the defaced components in accordance with ordinary household disposal practices and applicable local regulations. If your kit has already been used: You do not need to return used components. Please do not base medical decisions solely on that prior result and do not use any remaining units. If you have questions about your results or your health, consult your healthcare provider, who may recommend retesting using an FDA-authorized test that is appropriate for your situation. You may still contact us through the form for support or goodwill assistance regarding your order. Forwarding requirement for further distribution: If you further distributed the affected product(s) to other locations or customers, please immediately forward this notice to all downstream recipients and ensure they stop use/stop distribution, quarantine, and follow the disposition instructions.
- Quantity in commerce
- 33 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- EAN: 7340221700444; SKU: A-SPE; UDI-DI: None; Lot/Serial Number: All Lots;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0727-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0728-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0729-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0730-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0731-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0732-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0733-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0734-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0735-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0736-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0737-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0738-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0739-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0740-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0741-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0742-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0743-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0744-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0745-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0746-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0747-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0748-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0749-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0750-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0751-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0752-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0753-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0754-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0755-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0756-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0757-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0758-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0759-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0760-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0761-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0762-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0763-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0764-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0765-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0766-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0767-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0768-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0769-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0770-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0771-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0772-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0773-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0774-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0775-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0776-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0777-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0778-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0779-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0780-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0781-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0782-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0783-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0784-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0785-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0786-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0787-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0788-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0789-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0790-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0791-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0792-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0793-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0794-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0795-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0796-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0797-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0798-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0799-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0800-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0801-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0802-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0803-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0804-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0805-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0806-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0807-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0808-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0809-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0810-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0811-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0812-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0813-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0814-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0815-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0816-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0817-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0818-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.