Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2012 - (Recall #: Z-2062-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

Product Classification:

Class I

Date Initiated: June 8, 2012

Date Posted: August 22, 2012

Recall Number: Z-2062-2012

Event ID: 61747

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.

Status: Terminated

Product Quantity: 5925 domestic 2 international

Code Information:

120V Gold part numbers 0700-001-000 IFU 0700-001-700 230 V Gold 0700-002- 000, IFU 0700-002-707 Neptune 1 Gold Rover 0700-001-000 1/11/01 12/23/09 3/26/01 1/30/10 0700-001-700 Neptune 1 Gold Rover - International 0700-002-000 9/15/05 10/3/05 10/3/05 0700-002-707

Distribution Pattern:

Worldwide Distribution -- USA (nationwide) and country of: Canada. .

Voluntary or Mandated:

Voluntary: Firm initiated