FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.
- Recall number
- Z-1866-2008
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.
- Status
- Terminated
- Initiated
- 2008-05-09
- Posted
- 2008-09-16
- Terminated
- 2010-12-21
- Reason
- Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
- Root cause
- Other
- Action
- Sales representatives were notified via telephone, and recall product advisory notices will be sent to all consignees on 05/09/2009. Contact a Regulatory Affairs representative at 408-754-2161 or 408-754-2000 should you have any questions.
- Quantity
- 4500
- Distribution
- Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland
- Lot, serial or model codes
- Lot numbers 4023, 4105, 4158, 4360, 4524, 4585, 4740, 4862, 4880, 5070, 5211, and 5328
- 510(k) numbers
- ["K982542"]
- PMA numbers
- not on file
- Product code
- FCS
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- 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