FDA Medical Device Recalls (openFDA)
Cook Inc.: Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
- Recall number
- Z-0977-2020
- Recalling firm
- Cook Inc.
- Product
- Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
- Status
- Terminated
- Initiated
- 2019-01-04
- Posted
- not on file
- Terminated
- 2020-05-29
- Reason
- The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- Root cause
- Process control
- Action
- On January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.
- Quantity
- 13388 total
- Distribution
- Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.
- Lot, serial or model codes
- 7953153 8077981 8070702 NS8176831 7999744 7999746 8077986 8077988 8172070 8176832 8176833 8176834 NS7999747 NS8180869 7990863 8424316 8424317 8424318 NS7990867 7988039 7998403 7998404 8001365 8040131 8193749 8197930 8197931 8412989 8412990 8424332 7988039X 8003098 8506037 NS8018667 8594594 8197932 8594595 NS8197934 NS8417599 NS8417600 NS7998407 NS8033592 NS8033593
- 510(k) numbers
- ["K961446"]
- PMA numbers
- not on file
- Product code
- FAD
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- 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