Changchun Wancheng Bio-Electron Co., Ltd. 2026-02-11 Health serious FDA
Health · FDA · Recall #FDA-Z-1262-2026
Male Fertility Sperm Test for Home Use (Cassette) Recall
Issued February 11, 2026 · Changchun Wancheng Bio-Electron Co., Ltd.
In February 2026, Changchun Wancheng Bio-Electron Co., Ltd. recalled the Male Fertility Sperm Test for Home Use (Cassette), a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Male Fertility Sperm Test for Home Use (Cassette) right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Changchun Wancheng Bio-Electron Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Changchun Wancheng Bio-Electron Co., Ltd.
- Category
- Health
- Recall date
- February 11, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of TX, GA, CA.
- Recall number
- FDA-Z-1262-2026
- Made in
- China
- Issuing agency
- FDA
In context
- Changchun Wancheng Bio-Electron Co., Ltd. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.