FDA Device recall Z-1262-2026
Male Fertility Sperm Test for Home Use (Cassette)
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of Male Fertility Sperm Test for Home Use (Cassette) by Changchun Wancheng Bio Electron, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1262-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-22 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Changchun Wancheng Bio Electron |
| Distribution | US |
Product
Male Fertility Sperm Test for Home Use (Cassette)
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.
Identifiers
| code_info | Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1262-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.