Hemospray Endoscopic Hemostat
The hemostatic device has an issue with endoscope adherence and inability to spray powder.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Wilson-Cook Medical Inc., of Winston Salem, North Carolina, recalled the Hemospray Endoscopic Hemostat, a hemostatic device for endoscopic gastrointestinal use, because of an issue with endoscope adherence and inability to spray powder. The firm will provide an updated Instruction for Use (IFU).
The recall began on August 20, 2026, and was added to the FDA's Enforcement Report on September 16, 2026. Distribution was nationwide in the United States and worldwide, including many countries.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number is listed.
Hemospray Endoscopic Hemostat
- Model
- HEMO-7
- HEMO-10
- HEMO-7-EU
- HEMO-10-EU
Details
- Company began the recall
- Sold in
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 ID
- 99452
- Recall No.
- Z-3177-2026
- Company
- Wilson-Cook Medical Inc.Winston Salem, North Carolina
- Hazard
- Device defect
- Quantity recalled
- 121,241 units (U.S.-49240, O.U.S.-72001)
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
