The Recall Desk
ModerateFDA (Devices)·Z-0454-2013·Announced 2012-12-12

Stryker Neptune 2 Rover Recall Due to Castor Binding Defect

Stryker is recalling Neptune 2 Rover waste management systems because a castor design defect can cause the unit to bind, potentially leading to operator back pain.

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. The hazard involves physical strain and back pain from a mechanical defect (binding castors), which fits the criteria for moderate severity as it involves a risk of harm without reports of serious injury or death.

Plain-English summary

Stryker Instruments Division of Stryker Corporation is recalling 5,865 units of the Neptune 2 Rover waste management system. The recall involves units with reference number 0702-001-000 and lot numbers ranging from 0733700353 through 1036100423. These devices are mobile rover units used in operating rooms, surgical centers, and doctor's offices to suction and collect fluid waste, small debris, and electrocautery smoke from surgical sites.

The recall was initiated because an investigation found that the original castor design had the potential for the casters to bind. This binding compromises the Rover's ability to roll smoothly. As a result, operators may experience additional physical strain when moving the unit, which has been associated with multiple exposures resulting in back pain.

The affected units were distributed worldwide, including the United States, Pacific countries, EEMEA, Canada, Latin America, and Japan. Healthcare facilities and users should stop using the affected units and contact Stryker for instructions on how to proceed with the recall.

The recalled product

Product
Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid was
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Waste Management
Hazard
Affected units
5,865

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)

  • Part 0702-001-000 (120v) Lot 0733700353 through 1036100423

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.

See all 2 products in this recall →

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