Agency classClass IIOur severity:High FDA (Devices)·Z-2252-2023·Announced 2023-08-09

Fusion Lithotripsy Extraction Baskets recalled for mechanical defects

Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device recall involves mechanical defects that could impair proper function during a medical procedure. No injuries or illnesses are reported in the source text. The score reflects the risk-of-harm nature of the defect in the absence of reported patient harm.

Plain-English summary

Wilson-Cook Medical Inc. is recalling 393 units of the Fusion Lithotripsy Extraction Basket, Model FS-LXB-2X4, worldwide. These devices are intended for endoscopic removal of biliary stones and foreign bodies.

The recalled baskets may fail to advance or retract properly, or the drive wire may break or separate from the handle during use, with or without mechanical lithotripsy. These mechanical defects could prevent successful completion of the intended procedure.

Healthcare providers and facilities that have received these devices should immediately identify affected units by lot number and discontinue use. Affected lot numbers are provided in FDA recall notice Z-2252-2023. Physicians and medical staff should contact Wilson-Cook Medical for guidance on device disposition and replacement options.

The recalled product

Product: Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Manufacturer: Wilson-Cook Medical Inc.
Category: Medical Device — Endoscopic Surgical Instruments
Hazard: mechanical-failure
wire-breakage
device-malfunction
Affected units: 393

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI/DI 00827002482777
10827002482774
Lot Numbers: W4589620
W4589141
W4596704
W4715238
W4646708
W4644270
W4660182
W4715242
W4589620
W4664573
W4608745
W4670102
W4697072
W4697068
W4696416
W4620539
W4651764
W4670097

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Wilson-Cook Medical Inc.

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Same hazard · mechanical failure