Z-2253-2023Class II

Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets...

Name: Z-2253-2023 Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets...
Creator: Wilson-Cook Medical Inc.
Published: 2023-06-22
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2023-06-22 / Open, Classified / root cause: manufacturing process

FDA source

Wilson-Cook Medical Inc. began a recall of Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of... on 2023-06-22. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2253-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-22
Posted: 2023-07-28
Recalling firm: Wilson-Cook Medical Inc.
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.
Product code: FFL Dislodger, Stone, Basket, Ureteral, Metal
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cook Medical issued an URGENT: MEDICAL DEVICE REMOVAL notice to their consignees on 07/14/2023 by email or priority mail. The notice explained the issue, the risk, and requested the consignee cease use and return the affected product.
Quantity in commerce: 402 units
Distribution: Worldwide distribution.
Product codes and lots: 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, W4664043, W4589622, W4590893, W4590893, W4590893, W4594583, W4594583, W4594583, W4594583, W4594583, W4619627, W4619627, W4619627, W4619651, W4625160, W4625160, W4625160, W4631933, W4647697, W4647701, W4651755, W4651755, W4651765, W4651765, W4651765, W4664574, W4664574, W4660177, W4645764, W4622445, W4610273, W4610273, W4616520, W4625161, W4701899, W4554892, W4554892, W4622445, W4664043, W4701899, W4625161, W4647285, W4554892, W4647285, W4622445, W4702270, W4554892, W4554892, W4554892, W4635963, W4701897, W4616520, W4631139, W4631139, W4631139, W4693489, W4631139, W4644272, W4697073, W4697252, W4631535, W4616511, W4621105, W4609498, W4616511, W4609498, W4554892, W4610273, W4664042, W4693489, W4625161, W4662350, W4610273, W4635963, W4635963, W4647285, W4664043, W4625161, W4660177, W4663702, W4664043, W4701897, W4701899, W4702270, W4662350, W4662350, W4663702, W4664043, W4701897, W4609498, W4664042, W4663702, W4697764, W4664042, W4645764, W4635963, W4702262

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2253-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2252-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2253-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28

Product code FFL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)