FDA Device recall Z-0971-2020
Urethral Dilator Set, Global Product No. G14185
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Urethral Dilator Set, Global Product No. G14185 by Cook, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0971-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-04 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
Product
Urethral Dilator Set, Global Product No. G14185
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.
Identifiers
| code_info | 8401849 8404945 8404946 8417702 8404946X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0971-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.