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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95300

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 29, 2024
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

1 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 1

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

Z-0036-2025
Recall number
Z-0036-2025
Initiated
August 29, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Wilson-Cook Medical Inc.
Quantity
UPDATE-4,605 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of product have been manufactured with nonconforming raw materials.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of product have been manufactured with nonconforming raw materials.

Code information

HEMO-7, REF G56572 - UDI-DI 00827002565722; Lot numbers: W4849600, exp. 6/27/2027; W4849968, exp. 6/28/2027; W4849969, exp. 6/28/2027; W4849970, exp. 6/28/2027; W4849971, exp. 6/28/2027; W4849972, exp. 6/28/2027; W4850219, exp. 7/1/2027; W4850220, exp. 7/1/2027; W4850221, exp. 7/1/2027; W4850659, exp. 7/2/2027; W4850660, exp. 7/2/2027; W4850662, exp. 7/2/2027; W4851084, exp. 7/3/2027; W4851085, exp. 7/3/2027; W4851086, 7/3/2027; W4852285, exp. 7/10/2027; and W4852286, exp. 7/10/2027; and HEMO-10, REF G21049 - UDI-DI 00827002210493; Lot numbers: W4849973, exp. 6/28/2027; and W4850217, exp. 7/1/2027. UPDATED 11/4/2024 FOR EXPANSION OF LOT NUMBERS: HEMO-7, REF G56572: Lot numbers: W4843115, W4843116, W4843117, W4843118, W4843119, W4849594, W4849595, W4849596, W4849597, W4849599, W4851251, W4851252, W4851253, W4851254, W4851255, W4851256, W4851257, W4851590, W4851591, W4851592, W4851596, W4851660, W4851871, W4851872, W4851874, W4851876, W4851877, W4851878, W4851879, W4851880, W4852627, W4852628, W4853096, W4853097, W4853098, W4853099, W4853100, W4853101, W4853102, W4853104, W4853105, W4853462, W4853463, W4853464, W4853465, W4853468, W4853469, W4859532, W4859533, W4859891, W4859892, W4859894, W4859895, W4859896, W4859897, W4859898, W4859899, W4860112, W4853470, W4853471, W4853948, W4853949, W4853950, W4853952, W4853954, W4854699, W4854700, W4854702, W4854703, W4854704, W4854705, W4854706, W4855265, W4855266, W4855267, W4855269, W4855270, W4855271, W4855272, W4855696, W4855697, W4855701, W4856471, W4856889, W4856892, W4856893, W4856894, W4856895, W4857327, W4857719, W4858445, W4858449, W4858450, W4858452, W4858454, W4858869, W4859152, W4859529, W4859530, W4859531, W4845546, W4845880, W4845881, W4845882, W4845883, W4845884, W4845886, W4845889, W4846299, W4846301, W4846303, W4847081, W4847085, W4847495, W4847496, W4847497, W4847498, W4847499, W4847500, W4847504, W4847892, W4847893, W4847894, W4847896, W4848132, W4848709, W4848710, W4848711, W4848712, W4848713, W4848714, W4848715, W4848716, W4848717, W4849067, W4849068, W4849070, W4849071, W4849072, W4849074, W4849075, W4849593, W4843512, W4843513, W4843514, W4843515, W4843516, W4843517, W4843518, W4843520, W4843860, W4843861, W4843862, W4843863, W4843865, W4843867, W4843868, W4843869, W4844246, W4844247, W4844248, W4844249, W4844251, W4844252, W4844253, W4844254, W4844643, W4844644, W4844646, W4844647, W4844649, W4844651, W4845120, W4845121, W4845122, W4845124, W4845125, W4845538, W4845539, W4845540, W4845541, W4845542, W4845543, and W4845545. HEMO-10, REF G21049, Lot numbers: W4843112, W4843113, W4843519, W4843864, W4843866, W4844250, W4844645, W4845117, W4845537, W4845544, W4845885, W4845888, W4847502, W4847503, W4848136, W4848708, W4849066, W4849069, W4849592, W4849598, W4851258, W4851593, W4851873, W4852282, W4853103, W4853467, W4853945, W4854701, W4855273, W4855699, W4858447, W4858868, W4859528, W4859890, W4859893, W4860295, and W4860304. UPDATE FROM 1/20/2025 EXPANSION: HEMO-7, REF G56572 - Lot numbers W4845123, W4843511, and W4845887.

Distribution pattern

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Latvia, Luxembourg, Mexico, Myanmar, Netherlands, Norway, New Zealand, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, Thailand, and United Kingdom.