The Recall Desk
ModerateFDA (Devices)·Z-2212-2013·Announced 2013-09-25

Zeppessis Reprocessed Manifolds Recalled for Lack of FDA Clearance

Zeppessis Reprocessing is recalling reprocessed single-use manifolds for Stryker Neptune systems because they lack FDA 510(k) clearance and a validated cleaning protocol.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses or injuries. The hazard is regulatory (lack of clearance and validated cleaning), which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where harm is not yet reported.

Plain-English summary

Zeppessis Reprocessing, LLC is recalling reprocessed single-use manifolds (filters) intended for use with Stryker Neptune 1 and Neptune 2 Waste Management Systems. The affected products include single-port and four-port manifolds for both the Neptune 1 and Neptune 2 systems, identified by specific part numbers. These devices are used in operating rooms, surgical centers, and doctor's offices to collect and dispose of surgical fluid waste and smoke generated from electrocautery or laser devices.

The recall was initiated because the reprocessed manifolds lack FDA 510(k) clearance and do not have a validated cleaning protocol for reprocessing the used devices. The source text does not specify the quantity of units distributed or report any illnesses or injuries associated with the use of these products.

The affected products were distributed in the states of California, Idaho, Oregon, and Washington. Users of these devices should stop using the reprocessed manifolds and contact Zeppessis Reprocessing, LLC for further instructions regarding the recall.

The recalled product

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 fl
Manufacturer
Zeppessis Reprocessing, LLC
Category
Medical Device — Surgical Waste Management
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • -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).

Distribution

Distributed in 4 states:

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