# FDA recall Z-0978-2020

> **Cook Inc.** · Class II · device recall initiated 2019-01-04.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0978-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-04
- **Report date:** 2020-02-12
- **Termination date:** 2020-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0978-2020

## Citation

> AI Analytics. FDA recall Z-0978-2020. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0978-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*