CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report

Zeppessis' reprocessed single-use manifolds (filters) recalled

Zeppessis Reprocessing is recalling Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and, distributed in California, Idaho, Oregon, Washington. The recall was initiated on 16 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes-Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000); -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000); -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000).

Quantity recalledundetermined the distributed amounts

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2212-2013
FDA event ID: 66176
Recalling firm: Zeppessis Reprocessing, Garden City, ID
Classification: Class II
Status: Terminated
Recall initiated: 16 Aug 2013
FDA classified: 17 Sep 2013
Reported: 25 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

16 Aug 2013	Recall initiated by company
17 Sep 2013	Classified by FDA	+32 days
25 Sep 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

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

California Idaho Oregon Washington

Questions about this recall

Is Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and recalled?

Yes. Zeppessis Reprocessing recalled Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and on 16 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2212-2013.

Why was it recalled?

Which lots are affected?

-Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000); -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000); -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000).

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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