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)
Recall
- Recall Number
- Z-0807-2025
- Event Number
- 95856
- Firm
- Stryker Corporation
- FEI Number
- 3015967359
- Product Code
- GEI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 3, 2024
- Posted
- January 6, 2025
- Address
- 1941 Stryker Way, Portage, MI, 49002-9711
Description
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)
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
On December 3, 2024, the firm notified affected consignees via "Urgent Medical Device Field Action" letters dated December 2, 2024. Customers were instructed to locate Neptune S Waste Management Systems and to quarantine affected products at their facility; to contact their Stryker Sales Rep to schedule the replacement of the affected device; to complete Business Reply Form after scheduling replacement and email completed form to [email protected] and maintain information internally until all required action have been completed. Please contact Recall Coordinator at 269-290-0524 or [email protected] with questions or concerns. An URGENT Medical Device Field Action dated 10/13/25 was sent to customers. The purpose of this notification is to advise you that Stryker Instruments has expanded the scope of impacted lots for the Neptune S Waste Management System recall. Due to a distribution error, your facility may have received a recalled device. Next Steps: 1. Locate Neptune S Waste Management Systems and quarantine affected products at your facility Reference the catalog and affected serial numbers in the table above to know if your product is impacted. 2. Contact your Stryker Sales Rep. Your rep will help you schedule the repair of your Neptune device. 3. Complete Business Reply Form (BRF) Once you have scheduled your repair, fill out the attached BRF on page 2. Please email completed form to [email protected]. 4. Maintain this notification internally until all required actions have been completed. Please contact Brooke Thompson at 269-290-0524 or [email protected] with questions or concerns.
US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.
14 (Expanded to 21 units on 10/9/25)