Stryker Neptune 2 Rover Recall Due to Binding Casters
Stryker is recalling 154 Neptune 2 Rover units because a castor design defect can cause binding, leading to operator strain and back pain.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where physical injury (back pain) has been reported, but no serious injury or death is documented, fitting the High severity criteria.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 154 units of the Neptune 2 Rover Waste Management System. The recall involves specific units with reference number 0702-002-000 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.
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. The defect can result in additional physical strain on the operator, which has led to multiple reports of back pain.
The affected units were distributed worldwide, including the United States, Pacific countries, EEMEA, Canada, Latin America, and Japan. Users of these devices 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 ~230V ~ 50 Hz 12A REF 0702-002-000, 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 154
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 0702-002-000 (230v) 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.
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