Stryker Neptune Bronze Rover — Class I medical device recall Z-2063-2012
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2012-08-22, distributed nationwide. Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the
| Recall number | Z-2063-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2012-06-08 |
| Classified | 2012-08-14 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2016-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,075 |
| Reason classes | labeling |
| Model numbers | 0700-007-000, 0700-007-720 |
Product
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2063-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.