100V NEPTUNE 3 ROVER JAPANESE — Class II medical device recall Z-0807-2025
Ongoing recall by Stryker Corporation, reported 2025-01-15, distributed in GA, IL, WA. Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the functi
| Recall number | Z-0807-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2024-12-03 |
| Classified | 2025-01-06 |
| Reported by FDA | 2025-01-15 |
| Distributed | GA, IL, WA |
| Countries outside the US | JP, NL |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07613327381948, 07613327382068, 07613327382082, 07613327576887 |
| Lot numbers | 000, 000ES, 001, 002, 003, 0703, 0711, 2303501403, 2323610223, 2403600253, 2427418013, 2427418053, 2427418073, 2427418093, 2427418233, 2427418453, 2427418723, 2427418743, 2427419773, 2427423863, 2427423873, 2429720623, 2429720903, 2429720973, 2429721023, 2429721033, 2429721203, 2429721223 |
Product
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
Reason for recall
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0807-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.