Wilson-Cook Medical Inc. — 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 Des

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

Provider: FDA — device enforcement reference
Source observed: 8/20/2026, 12:00:00 AM UTC
Source updated: 9/16/2026, 12:00:00 AM UTC
Location: Winston Salem, NC, US
hazard: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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
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, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guatemala, Guadeloupe, Guernsey, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jersey, Japan, Kuwait, Latvia, Lithuania, Luxembourg, Malta, Martinique, Mexico, Myanmar, Macau, Monaco, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, El Salvador, South Africa, Spain, Sweden, Switzerland, Thailand, Taiwan, United Arab Emirates, United Kingdom, and Vietnam.
event number: 99452
manufacturer: Wilson-Cook Medical Inc.
recall number: Z-3177-2026
source status: Open, Classified
freshness minutes: 180

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Source use policy · openFDA reference data; not a real-time public alert service

Update history (1 recent revisions)

10/8/2026, 2:10:39 AM UTC

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