Recall archive / FDA device enforcement
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemo... — FDA record Z-0036-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- Specific lots of product have been manufactured with nonconforming raw materials.
- Classification
- Class II
- Recalling firm
- Wilson-Cook Medical Inc.
- Quantity
- UPDATE-4,605 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0036-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 23, 2024
- Recall initiation date
- Aug 29, 2024
- Center classification date
- Oct 17, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.