Stryker Neptune 2 Rover Ultra Waste Management System Field Upgrade Recall
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems to meet 510(k) clearance specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a voluntary precautionary field upgrade to meet regulatory specifications, with no reported injuries or illnesses.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling the Neptune 2 Rover Ultra Waste Management System. The recall involves Manufacturer Part Number 0702-001-000 (120V) with all serial numbers.
The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. The agency has classified this as a Class II recall.
The affected products were distributed nationwide and in Canada, Germany, Australia, and New Zealand. Users should contact Stryker Instruments to arrange the necessary field upgrade.
The recalled product
- Product
- Neptune 2 Rover Ultra Waste Management System.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- 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 (1)
- Manufacturer Part Number 0702-001-000 (120V) All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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