Recall Z-3177-2026 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
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 Description: Hemostatic device for endoscopic gastrointestinal use Component: No
| Date | Sep 16, 2026 (initiated Aug 20, 2026) |
| Status | Open, Classified |
| Reason | Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). |
| Root cause | Labeling design |
| Action | On 08/20/2026, an "URGENT: MEDICAL DEVICE CORRECTION" Letter was emailed to customer informing them of an updated Instruction for Use (IFU) to address two Hemospray potential issues: endoscope adhesion and inability to spray powder. Customers are instructed to: 1. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have subject product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 2. This notice must be shared with appropr |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) Wilson-Cook Medical, Inc., Jun 2, 2026 |