FDA Medical devices recall · September 23, 2026

HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT… recall

Read the official FDA notice ↗

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot Code: RPN: IHEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Order Number: G56572, G21049, G24663, G21346 Affected Lot Numbers and MFG/EXP Dates: The information supplied in this letter applies to all lot numbers of Hemospray. UDI: 00827002565722; 00827002210493; 00827002246638; 00827002213463 HEMO-7 Work Order Numbers: W4744012 W4744013 W4744014 W4744015 W4744016 W4744017 W4744103 W4744104 W4744504 W4744506 W4744507 W4744508 W4744509 W4744510 W4744511 W4744575 W4744576 W4744828 W4744829 W4744830 W4744831 W4744832 W4744834 W4744905 W4744906 W4745140 W4745141 W4745142 W4745144 W4745145 W4745146 W4745147 W4745262 W4745263 W4745408 W4745409 W4745411 W4745412 W4745488 W4745489 W4746024 W4746025 W4746026 W4746027 W4746028 W4746029 W4746030 W4746494 W4746495 W4746496 W4746497 W4746498 W4746499 W4746500 W4746639 W4746640 W4746909 W4746910 W4746911 W4746912 W4746913 W4746915 W4747100 W4747374 W4747375 W4747377 W4747378 W4747379 W4747380 W4747381 W4747802 W4747803 W4747805 W4747806 W4747807 W4748859 W4748860 W4748865 W4748866 W4748930 W4748931 W4749220 W4749221 W4749222 W4749223 W4749224 W4749225 W4749226 W4749422 W4749423 W4749736 W4749737 W4749738 W4749739 W4749740 W4749741 W4749742 W4749971 W4749972 W4749995 W4750254 W4750255 W4750256 W4750257 W4750259 W4750260 W4750444 W4750445 W4750465 W4750614 W4750616 W4750617 W4750618 W4750619 W4750873 W4750874 W4750904 W4751075 W4751076 W4751077 W4751078 W4751079 W4751080 W4751249 W4751250 W4751337 W4751501 W4751502 W4751503 W4751504 W4751740 W4751

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, 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.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-3177-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.