Stryker Corporation recalls 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002…

Recall date

December 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0807-2025

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)