HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name recall

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

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)

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Wilson-Cook Medical Inc., Winston Salem, NC

Date

Wednesday, September 23

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
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 Argentin…

Status

Ongoing

Recall number

Z-3177-2026

Source

U.S. Food and Drug Administration