Severity
Moderate
FDA Devices recall · Reported September 9, 2015
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…
Stryker Instruments Div. of Stryker Corporation recalled Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished … - a moderate-severity action.
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished … was recalled by Stryker Instruments Div. of Stryker Corporation in September 9, 2015. Reason: The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of speci…. Check the official notice for the remedy. Verify recall #Z-2524-2015 with the FDA Devices before acting.
The recall
Stryker Instruments Div. of Stryker Corporation issued this moderate-severity FDA Devices recall-The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of speci….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2524-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2524-2015) was formally reported on September 9, 2015, with the manufacturer initiating the action on July 20, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Instruments Div. of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 524, 237 of these are non-conforming.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, W…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
524, 237 of these are non-conforming
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2524-2015 |
| Date reported | September 9, 2015 |
| Date initiated | July 20, 2015 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 524, 237 of these are non-conforming |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 9, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.