Class II — Wilson-Cook Medical Inc.
| Recalling firm | Wilson-Cook Medical Inc. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). |
| 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 |
| Quantity | 121,241 units (U.S.-49240, O.U.S.-72001) |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Brazil, Canada, Canary Island, Chile, Col… |
| Initiated | 2026-08-20 |
| Classified | 2026-09-16 |
| Recall number | Z-3177-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Wilson-Cook Medical Inc. (Z-3177-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99452/
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