Z-0454-2013Class II

Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents...

Name: Z-0454-2013 Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2011-05-24
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2011-05-24 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg... on 2011-05-24. FDA classified it as Class II and gives the reason as "Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0454-2013
Classification: Class II
Status: Terminated
Initiated: 2011-05-24
Posted: 2012-12-03
Terminated: 2014-05-28
Recalling firm: Stryker Corp.
Product: Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.
Root cause tag: design
FDA root cause: Component design/selection
Action: Stryker Instruments sent a "STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to [email protected]. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052.
Quantity in commerce: 5865
Distribution: Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
Product codes and lots: Part 0702-001-000 (120v) Lot 0733700353 through 1036100423

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0454-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0454-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03
Z-0455-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03

Product code JCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)