FDA Device recall Z-3177-2026
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEM…
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEM… by Wilson Cook Medical, citing due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3177-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-20 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Wilson Cook Medical |
| Distribution | US |
Product
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No
Reason
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
Identifiers
| code_info | Lot Code: RPN: IHEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Order Number: G56572, G21049, G24663, G21346 Affected Lot Numb…Lot Code: RPN: IHEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Order Number: G56572, G21049, G24663, G21346 Affected Lot Numbers and MFG/EXP Dates: The information supplied in this letter applies to all lot numbers of Hemospray. UDI: 00827002565722; 00827002210493; 00827002246638; 00827002213463 HEMO-7 Work Order Numbers: W4744012 W4744013 W4744014 W4744015 W4744016 W4744017 W4744103 W4744104 W4744504 W4744506 W4744507 W4744508 W4744509 W4744510 W4744511 W4744575 W4744576 W4744828 W4744829 W4744830 W4744831 W4744832 W4744834 W4744905 W4744906 W4745140 W4745141 W4745142 W4745144 W4745145 W4745146 W4745147 W4745262 W4745263 W4745408 W4745409 W4745411 W4745412 W4745488 W4745489 W4746024 W4746025 W4746026 W4746027 W4746028 W4746029 W4746030 W4746494 W4746495 W4746496 W4746497 W4746498 W4746499 W4746500 W4746639 W4746640 W4746909 W4746910 W4746911 W4746912 W4746913 W4746915 W4747100 W4747374 W4747375 W4747377 W4747378 W4747379 W4747380 W4747381 W4747802 W4747803 W4747805 W4747806 W4747807 W47488 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3177-2026%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.