FDA-Device2026-09-23Class II
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
Hazard
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
Sold states
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.
Affected count
121,241 units (U.S.-49240, O.U.S.-72001)
Manufactured in
4900 Bethania Station Rd, N/A, Winston Salem, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3177-2026Want us to check the next one for you?
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