Neptune Medical Suction Rovers Recalled Due to Loose Bolts
Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.
What this means for you
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: FDA Class II medical device recall with a documented manufacturing defect affecting critical device function. The defect poses a direct risk of suction loss during surgical procedures, meeting the criteria for high-severity risk-of-harm products where no injuries have yet been reported.
Plain-English summary
Stryker Corporation is recalling certain Neptune 3 Rover and Neptune S Rover surgical suction systems. The affected models are: 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000), 120V NEPTUNE S ROVER (0711-001-000), 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG), and 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES).
The recall stems from bolts on the vacuum pump filter housing and flange plate that were not properly tightened during manufacturing. Systems with loose bolts may fail to provide sufficient suction force or experience complete loss of suction during medical procedures.
The recall affects 21 units distributed domestically to healthcare facilities in Washington, Georgia, and Illinois, as well as internationally to Japan and the Netherlands. Affected devices can be identified by specific lot numbers documented in the FDA recall notice.
Healthcare facilities and users with these devices should immediately contact Stryker Corporation for guidance on inspection, repair, or replacement options.
The recalled product
- Product
- 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
- Manufacturer
- Stryker Corporation
- Hazard
- manufacturing-defect
- loss-of-suction
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 (6)
- 0703 002 000ENG GTIN 07613327382082
- Lot Numbers
- 0703 002 000ES GTIN 07613327382068
- Lot Numbers: 2427418453
- 0703 003 000 GTIN 07613327381948
- 0711 001 000 GTIN 07613327576887
Distribution
Distributed in 3 states:
- GA
- IL
- WA
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