Data Foundry

Medical device recalls 2023

Fusion Lithotripsy Extraction Basket — Class II medical device recall Z-2253-2023

Ongoing recall by Wilson-Cook Medical Inc., reported 2023-08-09. Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wir

Recall numberZ-2253-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmWilson-Cook Medical Inc., Winston Salem, NC, United States
Recall initiated2023-06-22
Classified2023-07-28
Reported by FDA2023-08-09
Quantity402 units
UPC / GTIN / UDI-DI00827002482784, 10827002482781
Lot numbersW4554892, W4576227, W4589622, W4590893, W4594583, W4609498, W4610273, W4612934, W4616511, W4616520, W4619627, W4619651, W4621105, W4622445, W4625160, W4625161, W4631139, W4631535, W4631537, W4631933, W4635963, W4644272, W4645764, W4647285, W4647697, W4647701, W4651755, W4651765, W4660177, W4662350, W4663702, W4664042, W4664043, W4664574, W4693489, W4697073, W4697252, W4697764, W4701897, W4701899 and 3 more
Model numbersFS-LXB-3X6, G48278

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 for recall

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).

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-2253-2023. 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.