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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92648

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 22, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Wilson-Cook Medical Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2252-2023
Recall number
Z-2252-2023
Initiated
June 22, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Wilson-Cook Medical Inc.
Quantity
393 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

UDI/DI 00827002482777, 10827002482774, Lot Numbers: W4589620, W4589141, W4596704, W4596704, W4589141, W4715238, W4596704, W4715238, W4715238, W4646708, W4644270, W4596704, W4589141, W4589141, W4715238, W4646708, W4715238, W4660182, W4596704, W4660182, W4660182, W4589141, W4596704, W4660182, W4715242, W4644270, W4589620, W4664573, W4646708, W4660182, W4589141, W4589620, W4644270, W4660182, W4660182, W4589620, W4644270, W4596704, W4644270, W4664573, W4644270, W4644270, W4646708, W4715238, W4664573, W4608745, W4670102, W4697072, W4697068, W4697072, W4696416, W4660182, W4620539, W4620539, W4620539, W4651764, W4651764, W4670097, W4664041, W4661895, W4647284, W4589621, W4693149, W4645756, W4594582, W4596701, W4612933, W4647284, W4664041, W4612933, W4643861, W4645763, W4594582, W4589621, W4635967, W4631138, W4644271, W4645308, W4645755, W4645756, W4647284, W4631138, W4596701, W4597312, W4612932, W4664041, W4594582, W4594582, W4597312, W4645755, W4661895, W4645763, W4571161, W4608304, W4610258, W4612932, W4612933, W4635967, W4645755, W4645755, W4693149, W4610258, W4596701, W4597312, W4645308, W4647284, W4635967, W4645308, W4693149, W4645763, W4571161, W4597312, W4612933, W4631138, W4631932, W4631932, W4571161, W4662353, W4635967, W4608304, W4612932, W4661895, W4645756, W4635967, W4635967, W4631932, W4635967, W4612933, W4631138, W4645308, W4596701, W4608304, W4662353, W4693149, W4589621, W4612933, W4645755, W4647284, W4662353, W4610258, W4643861, W4644271, W4644271, W4645308, W4645763, W4596701, W4608304, W4608304, W4612932, W4619650, W4622436, W4631932, W4635967, W4631138, W4594582, W4643861, W4631932, W4645756, W4662353, W4664041, W4594582, W4589621, W4664041, W4662353, W4612933, W4612933, W4631138, W4612933, W4631138, W4596704, W4589141

Distribution pattern

Worldwide distribution.

device · product 2 of 2

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.

Z-2253-2023
Recall number
Z-2253-2023
Initiated
June 22, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Wilson-Cook Medical Inc.
Quantity
402 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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

Distribution pattern

Worldwide distribution.