- Recalling firm
- Wilson-Cook Medical Inc.
- Reason for recall
- Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
- Affected products (lot / model / serial)
- 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 W4751741 W4751742 W4751779 W4751897 W4751898 W4751899 W4751900 W4751901 W4752132 W4752133 W4752342 W4752343 W4752347 W4752348 W4752518 W4752519 W4752996 W4752997 W4752998 W4752999 W4753000 W4753001 W4753002 W4753197 W4753453 W4753454 W4753456 W4753457 W4753458 W4753459 W4753651 W4753652 W4753677 W4753879 W4753880 W4753881 W4753882 W4753885 W4753886 W4754061 W4754062 W4754326 W4754329 W4754330 W4754331 W4754332 W4754333 W4754504 W4754505 W4754731 W4754732 W4754733 W4754734 W4754735 W4754739 W4754740 W4755181 W4755182 W4755183 W4755184 W4755185 W4755186 W4755187 W4755190 W4755647 W4755648 W4755649 W4755650 W4755652 W4755653 W4755654 W4755745 W4755746 W4756180 W4756181 W4756182 W4756183 W4756184 W4756185 W4756255 W4756256 W4756538 W4756539 W4756540 W4756541 W4756542 W4756543 W4756544 W4756693 W4756694 W4756858 W4756860 W4756861 W4756862 W4756864 W4756865 W4756946 W4756947 W4757492 W4757940 W4757941 W4757943 W4757955 W4757956 W4758402 W4758403 W4758404 W4758710 W4758711 W4758712 W4758713 W4758714 W4758715 W4758754 W4758755 W4758878 W4758879 W4758880 W4758881 W4758882 W4759033 W4759034 W4759473 W4759476 W4759477 W4759613 W4759614 W4759963 W4759964 W4759965 W4759966 W4759969 W4759970 W4760122 W4760123 W4760429 W4760430 W4760433 W4760434 W4760435 W4760436 W4760669 W4760670 W4760849 W4760850 W4760851 W4760852 W4760853 W4760854 W4760855 W4760856 W4760971 W4760972 W4761286 W4761287 W4761288 W4761289 W4761290 W4761367 W4761368 W4761794 W4761795 W4761859 W4761860 W4761861 W4761862 W4761863 W4762113 W4762114 W4762115 W4762116 W4762117 W4762319 W4762320 W4762580 W4762581 W4762582 W4762583 W4762584 W4762585 W4762776 W4762777 W4762956 W4762957 W4762958 W4762960 W4762961 W4762962 W4763062 W4763063 W4763477 W4763478 W4763479 W4763480 W4763599 W4763600 W4763913 W4763914 W4763915 W4763916 W4763917 W4764051 W4764052 W4764415 W4764416 W4764417 W4764418 W4764419 W4764420 W4764421 W4764508 W4764509 W4765579 W4765580 W4765581 W4765584 W4765734 W4765735 W4766140 W4766141 W4766142 W4766143 W4766144 W4766145 W4766279 W4766280 W4766583 W4766584 W4766587 W4766588 W4766589 W4766697 W4766698 W4767046 W4767049 W4767050 W4767051 W4767052 W4767239 W4767240 W4767562 W4767563 W4767564 W4767565 W4767566 W4767568 W4767570 W4767790 W4767792 W4767794 W4767795 W4767796 W4768077 W4768078 W4768281 W4768282 W4768283 W4768286 W4768287 W4768401 W4768402 W4768558 W4768814 W4768815 W4768817 W4768818 W4768930 W4769286 W4769287 W4769288 W4769289 W4769375 W4769376 W4769378 W4769379 W4769792 W4769793 W4769794
- Units affected
- 121,241 units (U.S.-49240, O.U.S.-72001)
- Distribution pattern
- 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.
- Firm location
- Winston Salem, NC, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3177-2026
- Recall initiated
- August 20, 2026
- FDA classification date
- September 16, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99452
- Last updated on HTM Vibe
- September 29, 2026