🔍 RecallPedia

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Class I - Dangerous
🏥 Medical Devices Recalled: August 24, 2020 Alcon Research Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2364745H 10391-04 2383902H 10391-04 2388582H 10391-04 2397523H 10477-17 2346459H 10477-18 2383904H 1087-63 2353407H 1087-64 2395495H 11016-11 2350017H 11311-07 2403959H 11311-07 2406031H 11345-08 2363773H 11345-08 2363774H 11345-08 2363775H 11437-03 2362137H 11437-03 2379506H 11437-03 2385658H 11437-03 2394132H 11458-17 2370067H 11458-17 2375171H 11458-17 2390120H 11458-17 2393525H 11458-17 2400520H 11786-01 2347153H 11786-01 2380332H 1179-43 2379382H 1179-43 2384124H 1179-43 2384125H 1179-43 2388444H 1179-43 2388445H 11876-18 2362142H 11876-18 2369176H 11876-18 2379510H 1231-57 2365132H 1231-57 2369489H 1231-57 2372302H 1231-57 2383379H 1231-57 2391174H 1231-57 2393089H 1231-57 2399904H 1231-57 2401798H 1231-57 2403559H 12732-05 2394138H 12736-09 2365968H 12736-09 2375271H 12736-09 2390575H 12736-09 2392097H 12736-09 2395160H 12878-13 2384211H 12878-13 2385672H 12896-09 2358037H 12896-09 2376070H 12896-09 2385542H 12896-09 2387051H 12896-09 2394141H 12896-09 2395582H 13152-08 2384214H 13193-11 2372672H 13193-11 2394902H 13194-12 2346890H 13194-13 2363370H 13194-13 2369833H 13194-13 2377937H 13194-13 2390027H 13194-13 2391920H 13194-13 2392322H 13194-13 2396531H 13194-13 2400270H 13194-13 2402421H 13235-16 2324761H 13391-09 2315328H 13391-09 2343461H 13391-09 2350133H 13391-09 2357090H 13391-10 2370048H 13391-10 2378299H 13391-10 2380086H 13391-10 2390108H 13391-10 2393512H 13391-10 2396778H 13391-10 2399535H 13477-10 2357278H 13477-10 2361677H 13477-10 2363897H 13477-10 2365971H 13477-10 2370199H 13477-10 2375273H 13477-10 2380877H 13477-10 2390175H 13477-10 2392100H 13477-10 2394534H 13667-08 2346266H 13667-09 2361271H 13667-09 2365630H 13667-09 2378038H 13667-09 2383643H 13667-09 2396582H 13667-09 2400368H 13698-13 2384221H 13698-13 2387057H 13698-13 2394149H 13699-16 2362174H 13699-16 2389133H 13699-16 2392378H 13699-16 2399300H 13700-16 2366535H 13700-16 2388008H 13700-16 2396979H 13702-18 2362175H 13702-18 2379482H 13702-18 2389134H 13702-18 2392379H 13702-18 2395588H 13777-12 2369193H 13777-12 2389136H 13777-12 2392382H 13777-12 2396981H 13909-02 2362177H 13909-02 2385684H 14049-09 2358048H 14049-09 2369194H 14049-09 2379487H 14049-09 2387060H 14049-09 2389139H 14049-09 2392385H 14049-09 2395593H 14049-09 2399305H 14228-06 2376082H 14295-01 2322279H 14295-02 2400274H 14319-06 2373436H 14319-06 2385550H 14319-06 2389142H 14319-06 2392390H 14319-06 2395598H 14329-04 2385268H 14329-04 2401377H 14424-10 2356092H 14424-10 2357456H 14424-11 2361756H 14424-11 2363987H 14424-11 2370331H 14424-11 2373012H 14424-11 2380958H 14424-11 2390236H 14424-11 2392161H 14424-11 2395249H 14424-11 2400750H 14443-09 2365548H 14443-09 2377947H 14443-09 2383076H 14443-09 2393359H 14443-09 2396539H 14443-09 2400277H 14443-09 2402002H 14489-07 2389143H 14489-07 2392392H 14489-07 2396983H 14569-06 2349153H 14569-06 2372002H 14677-06 2359127H 14677-06 2363381H 14677-06 2377953H 14677-06 2379923H 14677-06 2387761H 14677-06 2387850H 14677-06 2388182H 14692-08 2358055H 14692-08 2358305H 14692-08 2369208H 14692-08 2376088H 14713-04 2353346H 14713-04 2355860H 14713-04 2365788H 14713-04 2367878H 14713-04 2373226H 14713-04 2374926H 14713-04 2392883H 14713-04 2396684H 14713-04 2398537H 14716-01 2350064H 14743-03 2343547H 14743-03 2357287H 14743-03 2365978H 14743-03 2367995H 14743-03 2370207H 14743-03 2378387H 14743-03 2383217H 14743-03 2390180H 14743-03 2392104H 14743-03 2398731H 14743-03 2400645H 14743-03 2402263H 14764-06 2319637H 14764-06 2371523H 14856-06 2373437H 14856-06 2379460H 14856-06 2385698H 14936-03 2376092H 15134-06 2348533H 15134-06 2392318H 15134-06 2392319H 15246-02 2380571H 15286-07 2319652H 15286-08 2367115H 15482-17 2383274H 15482-17 2387319H 15482-17 2392341H 15503-05 2369219H 15503-05 2376097H 15503-05 2376098H 15503-05 2385561H 15503-05 2395606H 15503-05 2396989H 15511-02 2366558H 15641-05 2362192H 15641-05 2369230H 15641-05 2379471H 15641-05 2385705H 15764-03 2379473H 15784-04 2384237H 15784-04 2399319H 15854-02 2384239H 15854-02 2385714H 16003-09 2399521H 16003-09 2399522H 16019-07 2395706H 16088-02 2317774H 16088-02 2319671H 16088-02 2349206H 16108-01 2389157H 16172-07 2346663H 16172-07 2348606H 16172-07 2399575H 16200-11 2358965H 16200-11 2365309H 16243-08 2342892H 16243-10 2365170H 16243-10 2369524H 16243-10 2387753H 16243-10 2387835H 16243-10 2388113H 16243-10 2397925H 16245-02 2374009H 16245-02 2395487H 16245-02 2399399H 16281-01 2376112H 16281-01 2388033H 1635-64 2357924H 1635-64 2366482H 1635-64 2376006H 1635-64 2385616H 1635-64 2389089H 1635-64 2392286H 1635-64 2396942H 16387-01 2362199H 16387-01 2387072H 16387-01 2401282H 16499-02 2376116H 16499-02 2379427H 1667-77 2389090H 1667-77 2392287H 16809-05 2373466H 16895-03 2384260H 16895-03 2385740H 16936-06 2357518H 16936-06 2390255H 16936-06 2392175H 16936-06 2394577H 16936-06 2396900H 16936-06 2400787H 16937-04 2359598H 16937-04 2370369H 16937-04 2390256H 16937-04 2394097H 16937-04 2396901H 16937-04 2398846H 16983-03 2319720H 17026-02 2358974H 17026-03 2367655H 17032-03 2385743H 17064-05 2363924H 17064-05 2370233H 17064-05 2372968H 17064-05 2390583H 17064-05 2393625H 17119-02 2373471H 17119-02 2385595H 17119-02 2395634H 17120-02 2387082H 17251-02 2340478H 17251-02 2340479H 17251-02 2342763H 17251-02 2350210H 17251-02 2370236H 17251-02 2372972H 17251-02 2375307H 17251-02 2378401H 17251-02 2380896H 17251-02 2391615H 17251-02 2392115H 17251-02 2394544H 17251-02 2396842H 17251-02 2398750H 17251-02 2398751H 17251-02 2402274H 17251-02 2403091H 17251-02 2403092H 17272-02 2373475H 17272-02 2385602H 17273-04 2354509H 17273-04 2373476H 17273-04 2384266H 17273-04 2387083H 17273-04 2389179H 17273-04 2392433H 17294-07 2348727H 17294-07 2348728H 17294-07 2361796H 17294-07 2364025H 17294-07 2370383H 17294-07 2375431H 17294-07 2383296H 17294-07 2390269H 17294-07 2392190H 17294-07 2395274H 17294-07 2398853H 17294-07 2400798H 17294-07 2401425H 17346-06 2358885H 17346-06 2360847H 17346-07 2365202H 17346-07 2372369H 17346-07 2374389H 17346-07 2378596H 17346-07 2391209H 17346-07 2393127H 17346-07 2396395H 17346-07 2397952H 17346-07 2399955H 17346-07 2403602H 17423-08 2374391H 17423-08 2383425H 17423-08 2393129H 17423-08 2399959H 17434-03 2380106H 17434-03 2390133H 17434-03 2392447H 17434-03 2392969H 17464-02 2357330H 17464-02 2359548H 17464-02 2366006H 17464-02 2368000H 17464-02 2370239H 17464-02 2375310H 17464-02 2380157H 17464-02 2390196H 17464-02 2392116H 17464-02 2394546H 17464-02 2396844H 17464-02 2398753H 17464-02 2400674H 17474-03 2385752H 17474-03 2392435H 17550-07 2347187H 17550-07 2369553H 17550-07 2372374H 17550-07 2374395H 17550-07 2382029H 17550-07 2389916H 17550-07 2392797H 17550-07 2394706H 17550-07 2396400H 17550-07 2399962H 1765-62 2358235H 1765-62 2368366H 1765-63 2399511H 17766-02 2391138H 17766-02 2397872H 17766-02 2399866H 17770-02 2394179H 17785-04 2366009H 17785-04 2378404H 17785-04 2380902H 17785-04 2390586H 17785-04 2395186H 17785-04 2402275H 17824-03 2395643H 17887-02 2355291H 17887-03 2394394H 17887-03 2396457H 17887-03 2398086H 17955-03 2355126H 17955-04 2378613H 17955-04 2382034H 17955-04 2396404H 17983-03 2394180H 17983-03 2395644H 18021-02 2359682H 18021-02 2368234H 18021-02 2371219H 18021-02 2373764H 18021-02 2381456H 18021-02 2382189H 18021-02 2384707H 18021-02 2399549H 18021-02 2401485H 18086-02 2373060H 18086-02 2383315H 18086-02 2390288H 18086-02 2393739H 18086-02 2394590H 18125-01 2376032H 18125-01 2399277H 18126-01 2358364H 18126-01 2385749H 18126-01 2388051H 18266-03 2367979H 18266-03 2378352H 18266-03 2380841H 18266-03 2388255H 18266-03 2400578H 18419-04 2363084H 18419-05 2367614H 18419-05 2369572H 18419-05 2372399H 18419-06 2378618H 18419-06 2388076H 18419-06 2388124H 18486-01 2359626H 18486-01 2370436H 18486-01 2381022H 18486-01 2388333H 18486-01 2390303H 18486-01 2392214H 18486-01 2395307H 18486-01 2396921H 18486-01 2401090H 18486-01 2401091H 18486-01 2401092H 18512-01 2367047H 18512-01 2370001H 18512-01 2382149H 18512-01 2383109H 18512-01 2388216H 18512-01 2389389H 18512-01 2391424H 18512-01 2393467H 18512-01 2395030H 18521-01 2375472H 18521-01 2395309H 18536-01 2380854H 18536-01 2386119H 18536-02 2393574H 18536-02 2401436H 18536-03 2396805H 18536-03 2398693H 18536-03 2400587H 18536-03 2400588H 18588-01 2391522H 18588-01 2392929H 18588-01 2396743H 18588-01 2398593H 18609-01 2394369H 18609-01 2397986H 1871-69 2387971H 1933-62 2320192H 1933-62 2343517H 1933-62 2363856H 1933-62 2370139H 1933-62 2375234H 1933-62 2380131H 1933-62 2388265H 1933-62 2388402H 1933-62 2402467H 2035-69 2349421H 2035-69 2364050H 2035-70 2368067H 2074-53 2376012H 2074-53 2385621H 2147-63 2315477H 2147-63 2363604H 2147-63 2365699H 2147-63 2378109H 2147-63 2390525H 2147-63 2392005H 2147-63 2395032H 2147-63 2395033H 2147-63 2403922H 2427-54 2379529H 2428-56 2349795H 2428-56 2363608H 2428-56 2378115H 2428-56 2380707H 2428-56 2383708H 2428-56 2393473H 2428-56 2398449H 2428-56 2400452H 2556-71 2350345H 2683-80 2357933H 2683-80 2385627H 2683-80 2392313H 2683-81 2394118H 2683-81 2399265H 2828-67 2376019H 4976-20 2370464H 4976-20 2373074H 4976-20 2375489H 4976-20 2378512H 4976-20 2391711H 4976-21 2395324H 5742-66 2379534H 5742-66 2395553H 5813-53 2366493H 5813-53 2384180H 5813-53 2385632H 6005-11 2373082H 6005-11 2375498H 6005-11 2378520H 6005-11 2396933H 6005-11 2398910H 6241-27 2319818H 6241-27 2320633H 6241-27 2343572H 6241-28 2357375H 6241-28 2363951H 6241-28 2366030H 6241-28 2370281H 6241-28 2378420H 6241-28 2380180H 6241-28 2383253H 6241-28 2395212H 6241-28 2398788H 6241-28 2400716H 6241-28 2401452H 6241-29 2402289H 6374-22 2365265H 6374-22 2369604H 6374-22 2372430H 6374-22 2382065H 6374-22 2388510H 6374-22 2388511H 6374-22 2391235H 6374-22 2392803H 6374-22 2398010H 6374-22 2398011H 6374-22 2400015H 6374-22 2400972H 6374-22 2400973H 6919-65 2354780H 6919-65 2354781H 6919-65 2354782H 6919-65 2354783H 6919-65 2361209H 6919-65 2361210H 6919-65 2361211H 6919-65 2363471H 6919-65 2363472H 6919-65 2377987H 6919-65 2379937H 6919-65 2379938H 6919-65 2379939H 6919-65 2383103H 6919-65 2383104H 6919-65 2393379H 6919-65 2393380H 6919-65 2394931H 6919-65 2394932H 6919-65 2398344H 6919-65 2398345H 6919-65 2400311H 6919-65 2400312H 6919-65 2400313H 6919-65 2402428H 6932-61 2343122H 6932-61 2349004H 6932-61 2359170H 6932-61 2363473H 6932-61 2390479H 6932-61 2393381H 6932-61 2396560H 6932-61 2398346H 6932-61 2400314H 8206-55 2385638H 8306-63 2379538H 8306-63 2385514H 8306-63 2387040H 8306-63 2389100H 8306-63 2392307H 8306-63 2395559H 8306-63 2399276H 8323-20 2363953H 8323-20 2363954H 8323-20 2366033H 8323-20 2366034H 8323-20 2375347H 8323-20 2375348H 8323-20 2388465H 8323-20 2388466H 8323-20 2388467H 8323-20 2393661H 8323-20 2396868H 8323-20 2396869H 8323-20 2398790H 8323-20 2400720H 8323-20 2400721H 8371-60 2362116H 8371-60 2376033H 8371-60 2384186H 8371-60 2387985H 8371-60 2395560H 8604-59 2360915H 8604-59 2369616H 8604-59 2377698H 8604-59 2380424H 8604-59 2391241H 8604-59 2393179H 8604-59 2394377H 8604-59 2398022H 8604-59 2398023H 8604-59 2400027H 8639-61 2400870H 8653-58 2362119H 8653-58 2373403H 8653-58 2385643H 8653-58 2389101H 8653-58 2392308H 8653-58 2395562H 8886-24 2319910H 8886-24 2361849H 8886-24 2369092H 8886-24 2390333H 8886-24 2393787H 8886-24 2402353H 9181-61 2385522H 9181-61 2395563H 9235-66 2363957H 9235-66 2370285H 9235-66 2375350H 9235-66 2380936H 9235-66 2390598H 9235-66 2392134H 9235-66 2394556H 9235-66 2396871H 9235-66 2398793H 9235-66 2400724H NVX-10008-14 JZ5030128 NVX-10008-14 JZ5030129 NVX-10008-15 JZ5031475 NVX-10008-15 JZ5031478 NVX-10008-15 JZ5031474 NVX-10008-15 JZ5031477 NVX-10008-15 JZ5031479 NVX-10008-15 JZ5031480 NVX-10008-15 JZ5031476 NVX-10391-04 JZ5040959 NVX-10477-18 JZ5042939 NVX-10477-18 JZ5037021 NVX-10477-18 JZ5036163 NVX-10477-18 JZ5036161 NVX-11016-11 JZ5040495 NVX-11016-11 JZ5039057 NVX-11016-11 JZ5030204 NVX-11017-09 JZ5040497 NVX-11017-09 JZ5039059 NVX-1179-43 JZ5039065 NVX-1179-43 JZ5035759 NVX-1179-43 JZ5035757 NVX-1179-43 JZ5035763 NVX-1179-43 JZ5035771 NVX-1179-43 JZ5035765 NVX-1179-43 JZ5035753 NVX-1179-43 JZ5035755 NVX-1179-43 JZ5035761 NVX-1179-43 JZ5035783 NVX-1179-43 JZ5035773 NVX-1179-43 JZ5035769 NVX-1179-43 JZ5035767 NVX-1179-43 JZ5035779 NVX-1179-43 JZ5035777 NVX-1179-43 JZ5035781 NVX-1179-43 JZ5035775 NVX-1179-43 JZ5035751 NVX-12609-07 JZ5040004 NVX-12609-07 JZ5037138 NVX-12622-13 JZ5039729 NVX-12622-13 JZ5039727 NVX-12622-13 JZ5037833 NVX-13001-15 JZ5039224 NVX-13157-07 JZ5041349 NVX-13157-07 JZ5037867 NVX-13235-16 JZ5029237 NVX-13235-16 JZ5029241 NVX-13235-16 JZ5029239 NVX-13235-17 JZ5032768 NVX-13235-17 JZ5032766 NVX-13235-17 JZ5037196 NVX-13235-17 JZ5037198 NVX-13235-17 JZ5036777 NVX-13235-17 JZ5036773 NVX-13235-17 JZ5036775 NVX-13512-08 JZ5036301 NVX-13512-10 JZ5041727 NVX-13512-10 JZ5041373 NVX-13512-10 JZ5037895 NVX-14569-06 JZ5042373 NVX-14569-06 JZ5041790 NVX-14569-06 JZ5041469 NVX-14716-01 JZ5029262 NVX-14716-02 JZ5040588 NVX-14716-02 JZ5040032 NVX-14764-06 JZ5033636 NVX-14764-07 JZ5043200 NVX-15134-06 JZ5038024 NVX-15134-06 JZ5030185 NVX-15134-06 JZ5030177 NVX-15134-06 JZ5030183 NVX-15134-06 JZ5030179 NVX-15134-06 JZ5030181 NVX-15286-08 JZ5041538 NVX-15286-08 JZ5029850 NVX-15286-08 JZ5029854 NVX-15286-08 JZ5029856 NVX-15286-08 JZ5029852 NVX-15286-08 JZ5029860 NVX-15286-08 JZ5029858 NVX-15562-05 JZ5042533 NVX-15562-05 JZ5038061 NVX-15562-05 JZ5030459 NVX-15698-06 JZ5040593 NVX-15698-06 JZ5038982 NVX-15857-11 JZ5039820 NVX-15857-11 JZ5037312 NVX-15857-11 JZ5036409 NVX-16003-09 JZ5042294 NVX-16003-09 JZ5042290 NVX-16003-09 JZ5042168 NVX-16003-09 JZ5042192 NVX-16003-09 JZ5042190 NVX-16003-09 JZ5042194 NVX-16003-09 JZ5042196 NVX-16003-09 JZ5042298 NVX-16003-09 JZ5042292 NVX-16003-09 JZ5042296 NVX-16003-09 JZ5029545 NVX-16019-07 JZ5041583 NVX-16019-07 JZ5041827 NVX-16019-07 JZ5038817 NVX-16019-07 JZ5038105 NVX-16088-03 JZ5035589 NVX-16088-03 JZ5035591 NVX-16088-03 JZ5035593 NVX-16088-03 JZ5035596 NVX-16088-03 JZ5035587 NVX-16088-03 JZ5035585 NVX-16088-03 JZ5035605 NVX-16088-03 JZ5035598 NVX-16088-03 JZ5035600 NVX-16088-03 JZ5035603 NVX-16200-11 JZ5042834 NVX-16200-11 JZ5042840 NVX-16200-11 JZ5039860 NVX-16200-11 JZ5038120 NVX-16200-11 JZ5038118 NVX-16382-04 JZ5042875 NVX-16382-04 JZ5042873 NVX-16382-04 JZ5040249 NVX-16382-04 JZ5040246 NVX-16382-04 JZ5040244 NVX-16382-04 JZ5040251 NVX-16382-04 JZ5040242 NVX-16382-04 JZ5039406 NVX-16382-04 JZ5039102 NVX-16382-04 JZ5019104 NVX-1765-62 JZ5029973 NVX-1765-62 JZ5029969 NVX-1765-62 JZ5029971 NVX-1765-62 JZ5029967 NVX-1765-62 JZ5029965 NVX-1765-63 JZ5040980 NVX-1765-63 JZ5040974 NVX-1765-63 JZ5040972 NVX-1765-63 JZ5040976 NVX-1765-63 JZ5040978 Q38631C 2387535H
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Alcon Research, LLC
Reason for Recall:
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Product Codes/Lot Numbers:

Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2364745H 10391-04 2383902H 10391-04 2388582H 10391-04 2397523H 10477-17 2346459H 10477-18 2383904H 1087-63 2353407H 1087-64 2395495H 11016-11 2350017H 11311-07 2403959H 11311-07 2406031H 11345-08 2363773H 11345-08 2363774H 11345-08 2363775H 11437-03 2362137H 11437-03 2379506H 11437-03 2385658H 11437-03 2394132H 11458-17 2370067H 11458-17 2375171H 11458-17 2390120H 11458-17 2393525H 11458-17 2400520H 11786-01 2347153H 11786-01 2380332H 1179-43 2379382H 1179-43 2384124H 1179-43 2384125H 1179-43 2388444H 1179-43 2388445H 11876-18 2362142H 11876-18 2369176H 11876-18 2379510H 1231-57 2365132H 1231-57 2369489H 1231-57 2372302H 1231-57 2383379H 1231-57 2391174H 1231-57 2393089H 1231-57 2399904H 1231-57 2401798H 1231-57 2403559H 12732-05 2394138H 12736-09 2365968H 12736-09 2375271H 12736-09 2390575H 12736-09 2392097H 12736-09 2395160H 12878-13 2384211H 12878-13 2385672H 12896-09 2358037H 12896-09 2376070H 12896-09 2385542H 12896-09 2387051H 12896-09 2394141H 12896-09 2395582H 13152-08 2384214H 13193-11 2372672H 13193-11 2394902H 13194-12 2346890H 13194-13 2363370H 13194-13 2369833H 13194-13 2377937H 13194-13 2390027H 13194-13 2391920H 13194-13 2392322H 13194-13 2396531H 13194-13 2400270H 13194-13 2402421H 13235-16 2324761H 13391-09 2315328H 13391-09 2343461H 13391-09 2350133H 13391-09 2357090H 13391-10 2370048H 13391-10 2378299H 13391-10 2380086H 13391-10 2390108H 13391-10 2393512H 13391-10 2396778H 13391-10 2399535H 13477-10 2357278H 13477-10 2361677H 13477-10 2363897H 13477-10 2365971H 13477-10 2370199H 13477-10 2375273H 13477-10 2380877H 13477-10 2390175H 13477-10 2392100H 13477-10 2394534H 13667-08 2346266H 13667-09 2361271H 13667-09 2365630H 13667-09 2378038H 13667-09 2383643H 13667-09 2396582H 13667-09 2400368H 13698-13 2384221H 13698-13 2387057H 13698-13 2394149H 13699-16 2362174H 13699-16 2389133H 13699-16 2392378H 13699-16 2399300H 13700-16 2366535H 13700-16 2388008H 13700-16 2396979H 13702-18 2362175H 13702-18 2379482H 13702-18 2389134H 13702-18 2392379H 13702-18 2395588H 13777-12 2369193H 13777-12 2389136H 13777-12 2392382H 13777-12 2396981H 13909-02 2362177H 13909-02 2385684H 14049-09 2358048H 14049-09 2369194H 14049-09 2379487H 14049-09 2387060H 14049-09 2389139H 14049-09 2392385H 14049-09 2395593H 14049-09 2399305H 14228-06 2376082H 14295-01 2322279H 14295-02 2400274H 14319-06 2373436H 14319-06 2385550H 14319-06 2389142H 14319-06 2392390H 14319-06 2395598H 14329-04 2385268H 14329-04 2401377H 14424-10 2356092H 14424-10 2357456H 14424-11 2361756H 14424-11 2363987H 14424-11 2370331H 14424-11 2373012H 14424-11 2380958H 14424-11 2390236H 14424-11 2392161H 14424-11 2395249H 14424-11 2400750H 14443-09 2365548H 14443-09 2377947H 14443-09 2383076H 14443-09 2393359H 14443-09 2396539H 14443-09 2400277H 14443-09 2402002H 14489-07 2389143H 14489-07 2392392H 14489-07 2396983H 14569-06 2349153H 14569-06 2372002H 14677-06 2359127H 14677-06 2363381H 14677-06 2377953H 14677-06 2379923H 14677-06 2387761H 14677-06 2387850H 14677-06 2388182H 14692-08 2358055H 14692-08 2358305H 14692-08 2369208H 14692-08 2376088H 14713-04 2353346H 14713-04 2355860H 14713-04 2365788H 14713-04 2367878H 14713-04 2373226H 14713-04 2374926H 14713-04 2392883H 14713-04 2396684H 14713-04 2398537H 14716-01 2350064H 14743-03 2343547H 14743-03 2357287H 14743-03 2365978H 14743-03 2367995H 14743-03 2370207H 14743-03 2378387H 14743-03 2383217H 14743-03 2390180H 14743-03 2392104H 14743-03 2398731H 14743-03 2400645H 14743-03 2402263H 14764-06 2319637H 14764-06 2371523H 14856-06 2373437H 14856-06 2379460H 14856-06 2385698H 14936-03 2376092H 15134-06 2348533H 15134-06 2392318H 15134-06 2392319H 15246-02 2380571H 15286-07 2319652H 15286-08 2367115H 15482-17 2383274H 15482-17 2387319H 15482-17 2392341H 15503-05 2369219H 15503-05 2376097H 15503-05 2376098H 15503-05 2385561H 15503-05 2395606H 15503-05 2396989H 15511-02 2366558H 15641-05 2362192H 15641-05 2369230H 15641-05 2379471H 15641-05 2385705H 15764-03 2379473H 15784-04 2384237H 15784-04 2399319H 15854-02 2384239H 15854-02 2385714H 16003-09 2399521H 16003-09 2399522H 16019-07 2395706H 16088-02 2317774H 16088-02 2319671H 16088-02 2349206H 16108-01 2389157H 16172-07 2346663H 16172-07 2348606H 16172-07 2399575H 16200-11 2358965H 16200-11 2365309H 16243-08 2342892H 16243-10 2365170H 16243-10 2369524H 16243-10 2387753H 16243-10 2387835H 16243-10 2388113H 16243-10 2397925H 16245-02 2374009H 16245-02 2395487H 16245-02 2399399H 16281-01 2376112H 16281-01 2388033H 1635-64 2357924H 1635-64 2366482H 1635-64 2376006H 1635-64 2385616H 1635-64 2389089H 1635-64 2392286H 1635-64 2396942H 16387-01 2362199H 16387-01 2387072H 16387-01 2401282H 16499-02 2376116H 16499-02 2379427H 1667-77 2389090H 1667-77 2392287H 16809-05 2373466H 16895-03 2384260H 16895-03 2385740H 16936-06 2357518H 16936-06 2390255H 16936-06 2392175H 16936-06 2394577H 16936-06 2396900H 16936-06 2400787H 16937-04 2359598H 16937-04 2370369H 16937-04 2390256H 16937-04 2394097H 16937-04 2396901H 16937-04 2398846H 16983-03 2319720H 17026-02 2358974H 17026-03 2367655H 17032-03 2385743H 17064-05 2363924H 17064-05 2370233H 17064-05 2372968H 17064-05 2390583H 17064-05 2393625H 17119-02 2373471H 17119-02 2385595H 17119-02 2395634H 17120-02 2387082H 17251-02 2340478H 17251-02 2340479H 17251-02 2342763H 17251-02 2350210H 17251-02 2370236H 17251-02 2372972H 17251-02 2375307H 17251-02 2378401H 17251-02 2380896H 17251-02 2391615H 17251-02 2392115H 17251-02 2394544H 17251-02 2396842H 17251-02 2398750H 17251-02 2398751H 17251-02 2402274H 17251-02 2403091H 17251-02 2403092H 17272-02 2373475H 17272-02 2385602H 17273-04 2354509H 17273-04 2373476H 17273-04 2384266H 17273-04 2387083H 17273-04 2389179H 17273-04 2392433H 17294-07 2348727H 17294-07 2348728H 17294-07 2361796H 17294-07 2364025H 17294-07 2370383H 17294-07 2375431H 17294-07 2383296H 17294-07 2390269H 17294-07 2392190H 17294-07 2395274H 17294-07 2398853H 17294-07 2400798H 17294-07 2401425H 17346-06 2358885H 17346-06 2360847H 17346-07 2365202H 17346-07 2372369H 17346-07 2374389H 17346-07 2378596H 17346-07 2391209H 17346-07 2393127H 17346-07 2396395H 17346-07 2397952H 17346-07 2399955H 17346-07 2403602H 17423-08 2374391H 17423-08 2383425H 17423-08 2393129H 17423-08 2399959H 17434-03 2380106H 17434-03 2390133H 17434-03 2392447H 17434-03 2392969H 17464-02 2357330H 17464-02 2359548H 17464-02 2366006H 17464-02 2368000H 17464-02 2370239H 17464-02 2375310H 17464-02 2380157H 17464-02 2390196H 17464-02 2392116H 17464-02 2394546H 17464-02 2396844H 17464-02 2398753H 17464-02 2400674H 17474-03 2385752H 17474-03 2392435H 17550-07 2347187H 17550-07 2369553H 17550-07 2372374H 17550-07 2374395H 17550-07 2382029H 17550-07 2389916H 17550-07 2392797H 17550-07 2394706H 17550-07 2396400H 17550-07 2399962H 1765-62 2358235H 1765-62 2368366H 1765-63 2399511H 17766-02 2391138H 17766-02 2397872H 17766-02 2399866H 17770-02 2394179H 17785-04 2366009H 17785-04 2378404H 17785-04 2380902H 17785-04 2390586H 17785-04 2395186H 17785-04 2402275H 17824-03 2395643H 17887-02 2355291H 17887-03 2394394H 17887-03 2396457H 17887-03 2398086H 17955-03 2355126H 17955-04 2378613H 17955-04 2382034H 17955-04 2396404H 17983-03 2394180H 17983-03 2395644H 18021-02 2359682H 18021-02 2368234H 18021-02 2371219H 18021-02 2373764H 18021-02 2381456H 18021-02 2382189H 18021-02 2384707H 18021-02 2399549H 18021-02 2401485H 18086-02 2373060H 18086-02 2383315H 18086-02 2390288H 18086-02 2393739H 18086-02 2394590H 18125-01 2376032H 18125-01 2399277H 18126-01 2358364H 18126-01 2385749H 18126-01 2388051H 18266-03 2367979H 18266-03 2378352H 18266-03 2380841H 18266-03 2388255H 18266-03 2400578H 18419-04 2363084H 18419-05 2367614H 18419-05 2369572H 18419-05 2372399H 18419-06 2378618H 18419-06 2388076H 18419-06 2388124H 18486-01 2359626H 18486-01 2370436H 18486-01 2381022H 18486-01 2388333H 18486-01 2390303H 18486-01 2392214H 18486-01 2395307H 18486-01 2396921H 18486-01 2401090H 18486-01 2401091H 18486-01 2401092H 18512-01 2367047H 18512-01 2370001H 18512-01 2382149H 18512-01 2383109H 18512-01 2388216H 18512-01 2389389H 18512-01 2391424H 18512-01 2393467H 18512-01 2395030H 18521-01 2375472H 18521-01 2395309H 18536-01 2380854H 18536-01 2386119H 18536-02 2393574H 18536-02 2401436H 18536-03 2396805H 18536-03 2398693H 18536-03 2400587H 18536-03 2400588H 18588-01 2391522H 18588-01 2392929H 18588-01 2396743H 18588-01 2398593H 18609-01 2394369H 18609-01 2397986H 1871-69 2387971H 1933-62 2320192H 1933-62 2343517H 1933-62 2363856H 1933-62 2370139H 1933-62 2375234H 1933-62 2380131H 1933-62 2388265H 1933-62 2388402H 1933-62 2402467H 2035-69 2349421H 2035-69 2364050H 2035-70 2368067H 2074-53 2376012H 2074-53 2385621H 2147-63 2315477H 2147-63 2363604H 2147-63 2365699H 2147-63 2378109H 2147-63 2390525H 2147-63 2392005H 2147-63 2395032H 2147-63 2395033H 2147-63 2403922H 2427-54 2379529H 2428-56 2349795H 2428-56 2363608H 2428-56 2378115H 2428-56 2380707H 2428-56 2383708H 2428-56 2393473H 2428-56 2398449H 2428-56 2400452H 2556-71 2350345H 2683-80 2357933H 2683-80 2385627H 2683-80 2392313H 2683-81 2394118H 2683-81 2399265H 2828-67 2376019H 4976-20 2370464H 4976-20 2373074H 4976-20 2375489H 4976-20 2378512H 4976-20 2391711H 4976-21 2395324H 5742-66 2379534H 5742-66 2395553H 5813-53 2366493H 5813-53 2384180H 5813-53 2385632H 6005-11 2373082H 6005-11 2375498H 6005-11 2378520H 6005-11 2396933H 6005-11 2398910H 6241-27 2319818H 6241-27 2320633H 6241-27 2343572H 6241-28 2357375H 6241-28 2363951H 6241-28 2366030H 6241-28 2370281H 6241-28 2378420H 6241-28 2380180H 6241-28 2383253H 6241-28 2395212H 6241-28 2398788H 6241-28 2400716H 6241-28 2401452H 6241-29 2402289H 6374-22 2365265H 6374-22 2369604H 6374-22 2372430H 6374-22 2382065H 6374-22 2388510H 6374-22 2388511H 6374-22 2391235H 6374-22 2392803H 6374-22 2398010H 6374-22 2398011H 6374-22 2400015H 6374-22 2400972H 6374-22 2400973H 6919-65 2354780H 6919-65 2354781H 6919-65 2354782H 6919-65 2354783H 6919-65 2361209H 6919-65 2361210H 6919-65 2361211H 6919-65 2363471H 6919-65 2363472H 6919-65 2377987H 6919-65 2379937H 6919-65 2379938H 6919-65 2379939H 6919-65 2383103H 6919-65 2383104H 6919-65 2393379H 6919-65 2393380H 6919-65 2394931H 6919-65 2394932H 6919-65 2398344H 6919-65 2398345H 6919-65 2400311H 6919-65 2400312H 6919-65 2400313H 6919-65 2402428H 6932-61 2343122H 6932-61 2349004H 6932-61 2359170H 6932-61 2363473H 6932-61 2390479H 6932-61 2393381H 6932-61 2396560H 6932-61 2398346H 6932-61 2400314H 8206-55 2385638H 8306-63 2379538H 8306-63 2385514H 8306-63 2387040H 8306-63 2389100H 8306-63 2392307H 8306-63 2395559H 8306-63 2399276H 8323-20 2363953H 8323-20 2363954H 8323-20 2366033H 8323-20 2366034H 8323-20 2375347H 8323-20 2375348H 8323-20 2388465H 8323-20 2388466H 8323-20 2388467H 8323-20 2393661H 8323-20 2396868H 8323-20 2396869H 8323-20 2398790H 8323-20 2400720H 8323-20 2400721H 8371-60 2362116H 8371-60 2376033H 8371-60 2384186H 8371-60 2387985H 8371-60 2395560H 8604-59 2360915H 8604-59 2369616H 8604-59 2377698H 8604-59 2380424H 8604-59 2391241H 8604-59 2393179H 8604-59 2394377H 8604-59 2398022H 8604-59 2398023H 8604-59 2400027H 8639-61 2400870H 8653-58 2362119H 8653-58 2373403H 8653-58 2385643H 8653-58 2389101H 8653-58 2392308H 8653-58 2395562H 8886-24 2319910H 8886-24 2361849H 8886-24 2369092H 8886-24 2390333H 8886-24 2393787H 8886-24 2402353H 9181-61 2385522H 9181-61 2395563H 9235-66 2363957H 9235-66 2370285H 9235-66 2375350H 9235-66 2380936H 9235-66 2390598H 9235-66 2392134H 9235-66 2394556H 9235-66 2396871H 9235-66 2398793H 9235-66 2400724H NVX-10008-14 JZ5030128 NVX-10008-14 JZ5030129 NVX-10008-15 JZ5031475 NVX-10008-15 JZ5031478 NVX-10008-15 JZ5031474 NVX-10008-15 JZ5031477 NVX-10008-15 JZ5031479 NVX-10008-15 JZ5031480 NVX-10008-15 JZ5031476 NVX-10391-04 JZ5040959 NVX-10477-18 JZ5042939 NVX-10477-18 JZ5037021 NVX-10477-18 JZ5036163 NVX-10477-18 JZ5036161 NVX-11016-11 JZ5040495 NVX-11016-11 JZ5039057 NVX-11016-11 JZ5030204 NVX-11017-09 JZ5040497 NVX-11017-09 JZ5039059 NVX-1179-43 JZ5039065 NVX-1179-43 JZ5035759 NVX-1179-43 JZ5035757 NVX-1179-43 JZ5035763 NVX-1179-43 JZ5035771 NVX-1179-43 JZ5035765 NVX-1179-43 JZ5035753 NVX-1179-43 JZ5035755 NVX-1179-43 JZ5035761 NVX-1179-43 JZ5035783 NVX-1179-43 JZ5035773 NVX-1179-43 JZ5035769 NVX-1179-43 JZ5035767 NVX-1179-43 JZ5035779 NVX-1179-43 JZ5035777 NVX-1179-43 JZ5035781 NVX-1179-43 JZ5035775 NVX-1179-43 JZ5035751 NVX-12609-07 JZ5040004 NVX-12609-07 JZ5037138 NVX-12622-13 JZ5039729 NVX-12622-13 JZ5039727 NVX-12622-13 JZ5037833 NVX-13001-15 JZ5039224 NVX-13157-07 JZ5041349 NVX-13157-07 JZ5037867 NVX-13235-16 JZ5029237 NVX-13235-16 JZ5029241 NVX-13235-16 JZ5029239 NVX-13235-17 JZ5032768 NVX-13235-17 JZ5032766 NVX-13235-17 JZ5037196 NVX-13235-17 JZ5037198 NVX-13235-17 JZ5036777 NVX-13235-17 JZ5036773 NVX-13235-17 JZ5036775 NVX-13512-08 JZ5036301 NVX-13512-10 JZ5041727 NVX-13512-10 JZ5041373 NVX-13512-10 JZ5037895 NVX-14569-06 JZ5042373 NVX-14569-06 JZ5041790 NVX-14569-06 JZ5041469 NVX-14716-01 JZ5029262 NVX-14716-02 JZ5040588 NVX-14716-02 JZ5040032 NVX-14764-06 JZ5033636 NVX-14764-07 JZ5043200 NVX-15134-06 JZ5038024 NVX-15134-06 JZ5030185 NVX-15134-06 JZ5030177 NVX-15134-06 JZ5030183 NVX-15134-06 JZ5030179 NVX-15134-06 JZ5030181 NVX-15286-08 JZ5041538 NVX-15286-08 JZ5029850 NVX-15286-08 JZ5029854 NVX-15286-08 JZ5029856 NVX-15286-08 JZ5029852 NVX-15286-08 JZ5029860 NVX-15286-08 JZ5029858 NVX-15562-05 JZ5042533 NVX-15562-05 JZ5038061 NVX-15562-05 JZ5030459 NVX-15698-06 JZ5040593 NVX-15698-06 JZ5038982 NVX-15857-11 JZ5039820 NVX-15857-11 JZ5037312 NVX-15857-11 JZ5036409 NVX-16003-09 JZ5042294 NVX-16003-09 JZ5042290 NVX-16003-09 JZ5042168 NVX-16003-09 JZ5042192 NVX-16003-09 JZ5042190 NVX-16003-09 JZ5042194 NVX-16003-09 JZ5042196 NVX-16003-09 JZ5042298 NVX-16003-09 JZ5042292 NVX-16003-09 JZ5042296 NVX-16003-09 JZ5029545 NVX-16019-07 JZ5041583 NVX-16019-07 JZ5041827 NVX-16019-07 JZ5038817 NVX-16019-07 JZ5038105 NVX-16088-03 JZ5035589 NVX-16088-03 JZ5035591 NVX-16088-03 JZ5035593 NVX-16088-03 JZ5035596 NVX-16088-03 JZ5035587 NVX-16088-03 JZ5035585 NVX-16088-03 JZ5035605 NVX-16088-03 JZ5035598 NVX-16088-03 JZ5035600 NVX-16088-03 JZ5035603 NVX-16200-11 JZ5042834 NVX-16200-11 JZ5042840 NVX-16200-11 JZ5039860 NVX-16200-11 JZ5038120 NVX-16200-11 JZ5038118 NVX-16382-04 JZ5042875 NVX-16382-04 JZ5042873 NVX-16382-04 JZ5040249 NVX-16382-04 JZ5040246 NVX-16382-04 JZ5040244 NVX-16382-04 JZ5040251 NVX-16382-04 JZ5040242 NVX-16382-04 JZ5039406 NVX-16382-04 JZ5039102 NVX-16382-04 JZ5019104 NVX-1765-62 JZ5029973 NVX-1765-62 JZ5029969 NVX-1765-62 JZ5029971 NVX-1765-62 JZ5029967 NVX-1765-62 JZ5029965 NVX-1765-63 JZ5040980 NVX-1765-63 JZ5040974 NVX-1765-63 JZ5040972 NVX-1765-63 JZ5040976 NVX-1765-63 JZ5040978 Q38631C 2387535H

Official Source

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FDA Recall Number: Z-0095-2021

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CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1

Alcon Research

Class I - Dangerous

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Sep 15, 2025 Other Medical Devices Nationwide View Details →

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

Alcon Research

Class I - Dangerous

Due to incomplete seals in the pouch which provide the sterile barrier.

Aug 5, 2025 Implants & Prosthetics Nationwide View Details →