FDA-Device2025-01-15Class II
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)
Stryker Corporation
Hazard
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.
Sold states
US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.
Affected count
14 (Expanded to 21 units on 10/9/25)
Manufactured in
1941 Stryker Way, Portage, MI, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2025Don't want to check this manually?
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