—#211411

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)

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K143145
Affected lot / code info: 0703 002 000ENG GTIN 07613327382082, Lot Numbers; 2427418723 2427423863 2427418453 2427423873 2427418743 2427419773; 0703 002 000ES GTIN 07613327382068, Lot Numbers: 2427418453; 0703 003 000 GTIN 07613327381948, Lot Numbers: 2427418093 2427418053 2427418073 2427418233 2427418013 2427418723; 0711 001 000 GTIN 07613327576887, Lot Numbers: 2429720623 2429721033 2429720903 2429721203 2429720973 2429721223 2429721023 2303501403 2323610223 2403600253;

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 instruments.recalls@stryker.com and maintain information internally until all required action have been completed. Please contact Recall Coordinator at 269-290-0524 or Instruments.recalls@stryker.com 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 instruments.recalls@stryker.com. 4. Maintain this notification internally until all required actions have been completed. Please contact Brooke Thompson at 269-290-0524 or Instruments.Recalls@stryker.com with questions or concerns.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.

Timeline

Recall initiated: 2024-12-03
Posted by FDA: 2025-01-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211411. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.