FDA Medical Device Recalls (openFDA)
Stryker Instruments, Instruments Div.: Stryker brand Neptune waste management system; model 711-27-1.
- Recall number
- Z-0524-03
- Recalling firm
- Stryker Instruments, Instruments Div.
- Product
- Stryker brand Neptune waste management system; model 711-27-1.
- Status
- Terminated
- Initiated
- 2002-12-03
- Posted
- 2003-02-01
- Terminated
- 2003-07-07
- Reason
- Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
- Root cause
- Other
- Action
- Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.
- Quantity
- 370
- Distribution
- United States
- Lot, serial or model codes
- All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01. The recalled caps can be visually distinguished because there is a flat lip where the lid connects to the unit, and the flat lip is covered by a metal retaining ring which holds the cap in place. Non-recalled units do not have a metal retaining ring, rather the caps are held in place by screws with ribs in the cap on either side of each screw.
- 510(k) numbers
- ["K990037","K012991"]
- PMA numbers
- not on file
- Product code
- FYD
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28