Agency classClass IIOur severity:High FDA (Devices)·Z-2253-2023·Announced 2023-08-09

Fusion Lithotripsy Extraction Basket Recalled for Mechanical Failure

Wilson-Cook Medical is recalling Fusion Lithotripsy Extraction Baskets due to mechanical failures that may prevent proper basket advancement or retraction during biliary stone removal procedures.

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 is an FDA Class II recall of a critical endoscopic device. The mechanical failures documented—inability to advance or retract the basket or drive wire breakage—could compromise the device's intended function and pose patient safety risks, although no adverse events are reported in the source.

Plain-English summary

Wilson-Cook Medical Inc. is recalling Fusion Lithotripsy Extraction Baskets, Model Number FS-LXB-3X6 G48278, intended for endoscopic removal of biliary stones and foreign bodies. This recall affects 402 units distributed worldwide.

Non-conforming units may exhibit mechanical failures: the basket may be unable to advance or retract properly, or the drive wire may break or separate from the handle. These failures may occur during use with or without mechanical lithotripsy and could prevent successful completion of the intended procedure.

Healthcare providers and patients should immediately discontinue use of affected baskets. For information on returning devices and obtaining replacements, contact Wilson-Cook Medical Inc.

The recalled product

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.
Manufacturer: Wilson-Cook Medical Inc.
Category: Medical Device — Endoscopic Surgical Instruments
Hazard: mechanical-failure
wire-breakage
Affected units: 402

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 00827002482784
10827002482781
Lot Numbers: W4631139
W4702268
W4631139
W4693489
W4576227
W4702262
W4616511
W4612934
W4609498
W4631537
W4644272
W4697764
W4660177
W4616520
W4610273
W4635963
W4622445
W4662350

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