Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 Recalled by Zeppessis Reprocessing, LLC Due to Zeppessis' reprocessed single-use manifolds (filters) for the Stryker...

Date: August 16, 2013
Company: Zeppessis Reprocessing, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zeppessis Reprocessing, LLC directly.

Affected Products

Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump.

Quantity: undetermined the distributed amounts

Why Was This Recalled?

Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds.

Where Was This Sold?

Distributed in the states of California, Idaho, Oregon, and Washington.

About Zeppessis Reprocessing, LLC

Zeppessis Reprocessing, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report