Z-2064-2012Class I

Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or...

Name: Z-2064-2012 Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2012-06-08
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2012-06-08 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical... on 2012-06-08. FDA classified it as Class I and gives the reason as "Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2064-2012
Classification: Class I
Status: Terminated
Initiated: 2012-06-08
Posted: 2012-08-15
Terminated: 2016-08-23
Recalling firm: Stryker Corp.
Product: Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Product code: FYD Apparatus, Exhaust, Surgical
Reason for recall: Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high flow device, to a passive drainage tube. June 12, 2012, customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Warning Labels, which are pending distribution, are required on all Neptune devices. Further investigation found the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. FDA advises Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Customers must confirm with Stryker via business reply form that they have completed these actions. Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 2 Bronze will receive a follow up mailing containing warning labels for the device and instructions detailing how to apply them. Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze without any further actions. On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992). As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices. 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. As such, FDA advises that the devices not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Nept
Quantity in commerce: 10,394 domestic, 276 international
Distribution: Worldwide Distribution -- USA (nationwide) and country of: Canada. .
Product codes and lots: Neptune 2 Rover Ultra (120 V) 0702-001-000 Neptune 2 Rover Ultra (230 V) 0702-002-000 associated IFU 0702-002-700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2064-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2061-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-14
Z-2062-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-14
Z-2063-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-14
Z-2064-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-14

Product code FYD

K012991Class IINeptune Waste Management StstemStryker Instruments / cleared 2001-11-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)