Vaginal pH Test Recall: Vivoo
FDA recalls 3,000 Vivoo Vaginal pH Test devices distributed nationwide in the United States, including Texas, Georgia, and California, because they were distributed before they could be legally marketed (510(k) clearance). The devices may produce false or inaccurate diagnostic results by a lay user and could lead to inappropriate medical intervention. Recall number: Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026).
| Brand | Changchun Wancheng Bio-Electron Co., Ltd. |
|---|---|
| Product | Vivoo Vaginal pH Test |
| Reason | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. |
| Severity | moderate |
| Units affected | 1000 |
| Distribution | US Nationwide distribution in the states of TX, GA, CA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Stop using the recalled Vivoo Vaginal pH Test and keep it in its original packaging.
- Check if you own a recalled unit using the recall number provided (Vivoo Vaginal pH Test/2024032219(03/21/2026)).
- Contact the seller or FDA for instructions on return, disposal, or replacement.
- If you have health concerns, consult a healthcare professional.
How to identify the recalled item
| Lot / date codes | Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026) |
|---|---|
| Lot / date codes | Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027) |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.