FDA Device recall Z-0036-2025
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile by Wilson Cook Medical, citing specific lots of product have been manufactured with nonconforming raw materials.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0036-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-29 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wilson Cook Medical |
| Distribution | US |
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.
Identifiers
| code_info | HEMO-7, REF G56572 - UDI-DI 00827002565722; Lot numbers: W4849600, exp. 6/27/2027; W4849968, exp. 6/28/2027; W4849969,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Wilson Cook Medical
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FDA Device · Class II · 2026-09-23 · Wilson Cook Medical - Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
FDA Device · Class II · 2026-04-22 · Wilson Cook Medical - Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number:…
FDA Device · Class II · 2026-02-25 · Wilson Cook Medical - Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
FDA Device · Class II · 2026-02-11 · Wilson Cook Medical - Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile
FDA Device · Class II · 2024-12-11 · Wilson Cook Medical
All Wilson Cook Medical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0036-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.