Z-2212-2013Class II

Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste...

Name: Z-2212-2013 Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste...
Creator: Zeppessis Reprocessing, LLC
Published: 2013-08-16
License: https://open.fda.gov/license/

Zeppessis Reprocessing, LLC / initiated 2013-08-16 / Terminated

FDA source

Zeppessis Reprocessing, LLC began a recall of Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is... on 2013-08-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2212-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-16
Posted: 2013-09-17
Terminated: 2013-11-08
Recalling firm: Zeppessis Reprocessing, LLC
Product: 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.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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.
FDA root cause: Reprocessing Controls
Action: Zeppessis Reprocessing, LLC sent an Urgent Medical Device Recall letter dated September 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to stop using the Zeppessis reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems immediately and instructed to destroy the products in a proper manner. Customers should fill out the Customer Response form and fax or email it back to Zeppessis. For any questions about this recall, please call Zeppessis Reprocessing, LLC at 208-559-7064.
Quantity in commerce: undetermined the distributed amounts
Distribution: Distributed in the states of California, Idaho, Oregon, and Washington.
Product codes and lots: -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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2212-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2212-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17

Product code JCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)