Universa Soft Ureteral Stent — Class II medical device recall Z-0978-2020
Terminated recall by Cook Inc., reported 2020-02-12, distributed nationwide. The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guid
| Recall number | Z-0978-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-01-04 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2020-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BO, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FR, GB, GT, HN, HR, HU, IE, IN, IT, JP, KR, LU, MT, MX, MY, NL, NZ, OM, PA, PL, PY, RO, SE, TT, TW, ZA |
| Quantity | 13,388 total |
Product
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726
Reason for recall
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.
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-0978-2020. 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.