FDA (Devices) recall action 67191
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.
The agency’s own wording, quoted from the enforcement report.
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems to meet 510(k) clearance specifications.
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.