FDA Device recall Z-2253-2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278 by Wilson Cook Medical, citing non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lith….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2253-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-22 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wilson Cook Medical |
| Distribution | n/a |
Product
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Reason
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
Identifiers
| code_info | UDI/DI 00827002482784, 10827002482781, Lot Numbers: W4631139, W4702268, W4631139, W4631139, W4693489, W4693489, W45762…UDI/DI 00827002482784, 10827002482781, Lot Numbers: W4631139, W4702268, W4631139, W4631139, W4693489, W4693489, W4576227, W4702262, W4693489, W4616511, W4693489, W4612934, W4609498, W4693489, W4609498, W4576227, W4631537, W4644272, W4693489, W4702262, W4576227, W4616511, W4612934, W4576227, W4631537, W4644272, W4631537, W4616511, W4702262, W4576227, W4612934, W4576227, W4612934, W4612934, W4612934, W4693489, W4631537, W4644272, W4609498, W4609498, W4702262, W4576227, W4612934, W4576227, W4631537, W4697764, W4576227, W4616511, W4631537, W4697764, W4644272, W4697764, W4702262, W4616511, W4697764, W4702262, W4660177, W4616520, W4610273, W4616520, W4616520, W4635963, W4622445, W4662350, W4645764, W4616520, W4625161, W4701899, W4622445, W4647285, W4647285, W4647285, W4635963, W4645764, W4663702, W4701899, W4645764, W4554892, W4663702, W4701899, W4702270, W4645764, W4616520, W4622445, W4645764, W4660177, W4645764, W4701897, W4702270, W4662350, W4663702, W4662350, W4610273, W4554892, W466404 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2253-2023%22
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