Z-1866-2008

Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with...

Name: Z-1866-2008 Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with...
Creator: Stryker Endoscopy
Published: 2008-05-09
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-05-09 / Terminated

FDA source

Stryker Endoscopy began a recall of Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic... on 2008-05-09. The reason FDA records is "Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1866-2008
Status: Terminated
Initiated: 2008-05-09
Posted: 2008-09-16
Terminated: 2010-12-21
Recalling firm: Stryker Corp.
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.
Product code: FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Reason for recall: Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
FDA 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 in commerce: 4500
Distribution: Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland
Product codes and lots: Lot numbers 4023, 4105, 4158, 4360, 4524, 4585, 4740, 4862, 4880, 5070, 5211, and 5328

Product code FCS

K982542Class IIStryker Ureteral Illuminator System IIIStryker Endoscopy / cleared 1998-09-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)