Recall archive / FDA device enforcement
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-0... — FDA record Z-0807-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Stryker Corporation
- Quantity
- 14 (Expanded to 21 units on 10/9/25)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0807-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 0703 002 000ENG GTIN 07613327382082, Lot Numbers; 2427418723 2427423863 2427418453 2427423873 2427418743 2427419773; 0703 002 000ES GTIN 07613327382068, Lot Numbers: 2427418453; 0703 003 000 GTIN 07613327381948, Lot Numbers: 2427418093 2427418053 2427418073 2427418233 2427418013 2427418723; 0711 001 000 GTIN 07613327576887, Lot Numbers: 2429720623 2429721033 2429720903 2429721203 2429720973 2429721223 2429721023 2303501403 2323610223 2403600253; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 15, 2025
- Recall initiation date
- Dec 3, 2024
- Center classification date
- Jan 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.