Recall Z-3177-2026— Wilson-Cook Medical Inc.

Name: FDA recall Z-3177-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Class II · Ongoing

Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2026-08-20. It names one FDA 510(k) clearance: K253302. 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. Reason: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU)..

Recalling firm: Wilson-Cook Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-20
Firm location: Winston Salem, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K253302 — Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc.·cleared 2026-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.