Recall Z-0807-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
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)
| Date | Jan 6, 2025 (initiated Dec 3, 2024) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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 |
| Quantity | 14 (Expanded to 21 units on 10/9/25) |
| Distribution | US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143145 | SafeAir Smoke Pencil Lina Medical Aps, Dec 4, 2014 |