Stryker Neptune 2 Rover Ultra Waste Management System Field Upgrade
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.
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 explicitly states the purpose is a field upgrade to meet clearance specifications and does not report any illnesses, injuries, or deaths. Per the rubric, when no harm is reported and the hazard is theoretical or procedural, the score is capped at 3, but given the lack of reported adverse events and the nature of a compliance upgrade, it aligns with Moderate severity for a Class II recall without reported harm.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is conducting a field upgrade for the Neptune 2 Rover Ultra Waste Management System. The purpose of this action is to upgrade the systems in the field to the recently obtained 510(k) clearance specifications.
The affected product is the Neptune 2 Rover Ultra Waste Management System, specifically Manufacturer Part Number 0702-002-000 (230V) with all serial numbers. The distribution pattern for these units includes the United States, Canada, Germany, and Australia, and New Zealand.
This recall is a Class II recall. The source text does not report any illnesses, injuries, or deaths associated with this product. The action is taken to ensure the devices meet the required regulatory clearance specifications.
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 0702-002-000 (230V) 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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