FDA Device recall Z-2524-2015
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker)…
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker)… by Stryker Instruments Div, citing the Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak betw….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2524-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-20 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suction and collect fluid waste and surgical smoke from a surgical site in an operating room. After collection, the Docker is mated to the Rover and the emptying of fluid waste and cleaning of the canisters occurs automatically. The Actuator Assembly is a component located within the Docker which consists of the fluid coupling parts under a spring loaded cover. Intended Use: The Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor s offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.
Reason
The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.
Identifiers
| code_info | Manufacturer Part Numbers: 0702-014-000 & 0702-014-000U, Manufactured between January 15, 2015 and June 3, 2015; Serial…Manufacturer Part Numbers: 0702-014-000 & 0702-014-000U, Manufactured between January 15, 2015 and June 3, 2015; Serial#s: 1026700963 1510408963 1503405703 1433809743 1433809663 1430301263 1430301273 1433809713 1513817133 1433503393 1433809793 1433809833 1430301223 1430301243 1433503413 1434307493 1434906993 1504406063 1429506183 1504406173 1504405953 1504406053 1429506103 1504406133 1504406143 1510018143 1504405923 1504405963 1504405973 1434906973 1430707693 1433503363 1433503433 1514600693 1504911693 1504911713 1514706073 1514706083 1514100683 1514600713 1429506113 1429506153 1512920853 1419502453 1420204963 1513817123 1418110743 1511700023 1511700033 1513817113 1514100663 1504406013 1506316103 1504911613 1504911623 1513817153 1430301433 1429705503 1106800303 1429705483 1506316123 1430301553 142970549 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2524-2015%22
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