Home male fertility tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states the devices may give false or inaccurate results leading to inappropriate medical intervention, and no injuries are reported.
Plain-English summary
This recall by Changchun Wancheng Bio-Electron Co., Ltd. covers the Male Fertility Sperm Test for Home Use (Cassette).
The record states that 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, and that the devices may cause a false or inaccurate diagnostic result by a lay person and lead to inappropriate medical intervention.
The record lists 1,000 units, with product names, lot numbers and expiration dates recorded in the enforcement record. The record gives distribution as US nationwide in the states of Texas, Georgia and California. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Consumers should follow the seller's return instructions and speak to a clinician rather than relying on a result from an affected test.
The recalled product
- Product
- Male Fertility Sperm Test for Home Use (Cassette)
- Manufacturer
- Changchun Wancheng Bio-Electron Co., Ltd.
- Category
- Medical Device — Test strip
- Affected units
- 1,000
Distribution
Part of a larger recall action
This product is one of 11 recalled by Changchun Wancheng Bio-Electron Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Changchun Wancheng Bio-Electron Co., Ltd.
See all →- HighVaginal pH tests recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighTyphoid antigen tests recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighExploro fertility tests recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighUrinalysis test strips recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighMenopause test cassettes recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
Same hazard · premarket clearance
See all →- ModerateNAEOTOM Alpha software applications recalled because they lack FDA clearance
FDA (Devices) · 2026-02-11
- ModerateCT software applications recalled because they lack FDA clearance
FDA (Devices) · 2026-02-11