Cook Medical Hemo-7 Hemospray Endoscopic Hemostat — Class II medical device recall Z-0036-2025
Ongoing recall by Wilson-Cook Medical Inc., reported 2024-10-23, distributed nationwide. Specific lots of product have been manufactured with nonconforming raw materials.
| Recall number | Z-0036-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wilson-Cook Medical Inc., Winston Salem, NC, United States |
| Recall initiated | 2024-08-29 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CR, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, GT, HK, IE, IT, LU, LV, MX, NL, NO, NZ, PL, PT, RO, SE, SG, TH |
| Quantity | 4,605 devices |
| UPC / GTIN / UDI-DI | 00827002210493, 00827002565722 |
| Lot numbers | HEMO-10, HEMO-7, W4843112, W4843113, W4843115, W4843116, W4843117, W4843118, W4843119, W4843511, W4843512, W4843513, W4843514, W4843515, W4843516, W4843517, W4843518, W4843519, W4843520, W4843860, W4843861, W4843862, W4843863, W4843864, W4843865, W4843866, W4843867, W4843868, W4843869, W4844246, W4844247, W4844248, W4844249, W4844250, W4844251, W4844252, W4844253, W4844254, W4844643, W4844644 and 205 more |
| Model numbers | 2.8, 3.7, G21049, G56572 |
| Expiration dates | 2027-06-27, 2027-06-28, 2027-07-01, 2027-07-02, 2027-07-03, 2027-07-10 |
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 for recall
Specific lots of product have been manufactured with nonconforming raw materials.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0036-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.