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Stryker Neptune Injury Lawsuits - Neptune Waste Management Systems Recalled

Stryker Neptune Injury Lawsuits -
Neptune Waste Management Systems Recalled

Stryker Neptune injury lawsuits - FDA & Stryker Neptune recalls

Stryker Neptune injury lawsuits -
FDA & Stryker Neptune recalls

Our firm is investigating potential lawsuits on behalf of patients who suffered an injury from Stryker’s Neptune Waste Management System. The systems, which are used to collect fluid and waste in operating rooms and surgical facilities, have been recalled due to reports of serious complications and death. According to the U.S. Food and Drug Administration (FDA), the Neptune 1 and Neptune 1 systems can cause potentially fatal side effects including major bleeding, soft tissue damage and organ damage when used incorrectly.

Class I Recall Following Reports of Injury, Death

In June 2012, Stryker recalled the following products:

  • Neptune 1 Gold Rover
  • Neptune 1 Gold Rover-International
  • Neptune 1 Silver Rover
  • Neptune Bronze
  • Neptune 2 Rover Ultra (120 V)
  • Neptune 2 Rover Ultra (230 V)

The recall came after the FDA and Stryker received a report of one patient injury and one death associated with the
Neptune 2. According to the FDA, the injury and death were related to using the high-flow, high-suction system incorrectly.
In particular, the Neptune 2 was connected to a passive chest drainage tube after an operation, lead to a patient death. The FDA states that the product instructions failed to properly warn against this action. The agency states that “When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.”

The devices above were issued a class I recall, which is the FDA’s most serious recall status. A class I recall indicates that exposure to the device or product has a reasonable chance of causing serious health problems or death.

Stryker Neptune Recall Expanded Due to Lack of FDA Approval

In September 2012, Stryker expanded the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V)because the FDA asserts that the devices have not been properly approved. According to a press release by Stryker, the devices are supposed to have clearance through the 510(k) process, but do not currently have it. Therefore, the release states, “At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined.”

Stryker claims to have stopped distributing the products.  In the meantime, the FDA has advised against using the waste management systems. The only potential exception may be in patients who have no other alternative. In these cases, the risks and benefits must be weighed carefully.

Legal Help for Victims of Stryker Neptune Waste Management Injuries

If you or a loved one suffered injuries related to the Stryker Neptune Waste Management System, you may have valuable legal rights. Please fill out our online form or call one of our experienced personal injury lawyers today at 1(800)-YOURLAWYER (1-800-968-7529) for a free evaluation of your case.


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FDA Sends Warning Letter to Stryker Corp. on Quality Issues, Marketing Practices and Failure to Notify Agency of Recall

Mar 12, 2013
The U.S. Food and Drug Administration (FDA) has sent a warning letter to Stryker Corporation, an orthopedic implant manufacturer, over quality concerns at its Portage, Michigan, manufacturing facility.The warning letter followed an inspection of the Stryker facility in November 2012, Reuters reports.  In addition to the quality system issues, the letter also said that Stryker had failed to notify the FDA of a product recall and had been marketing some devices, including the Neptune Waste...

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