Z-0807-2025Class II

100V Neptune 3 Rover Japanese (0703-003-000) 120V Neptune S Rover (0711-001-000) 230V Neptune 3 Rover English...

Name: Z-0807-2025 100V Neptune 3 Rover Japanese (0703-003-000) 120V Neptune S Rover (0711-001-000) 230V Neptune 3 Rover English...
Creator: Stryker Corporation
Published: 2024-12-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-12-03 / Open, Classified

FDA source

Stryker Corporation began a recall of 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... on 2024-12-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0807-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-03
Posted: 2025-01-06
Recalling firm: Stryker Corp.
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)
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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.
FDA 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 [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.
Quantity in commerce: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0807-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0807-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-06

Product code GEI

K143145Class IISafeAir Smoke PencilLina Medical Aps / cleared 2014-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)