Class 2 Device Recall OmniTract

• Date Initiated by Firm: June 05, 2026
• Date Posted: July 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2714-2026
• Recall Event ID: 99193
• Product Classification: Retractor - Product Code GAD
• Product: OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
• Code Information: Product Code 3032, UDI 10381780268468; Product Code 3055, UDI 10381780268505; Product Code 3069, UDI 10381780268512; Product Code 3076, UDI 10381780268529; Product Code 3086, UDI 10381780268536; Product Code 3092, UDI 10381780268550; Product Code 3093, UDI 10381780268567; Product Code 3096, UDI 10381780268581; Product Code 3098, UDI 10381780268598; Product Code 3099, UDI 10381780268604; Product Code 3133, UDI 10381780268680; Product Code 3137, UDI 10381780268697; Product Code 3142, UDI 10381780268710; Product Code 3146, UDI 10381780268734; Product Code 3148, UDI 10381780268758; Product Code 3176, UDI 10381780268826; Product Code 3177, UDI 10381780268833; Product Code 3185, UDI 10381780268857; Product Code 3201, UDI 10381780268871; Product Code 3203, UDI 10381780268888; Product Code 3216, UDI 10381780268895; Product Code 3217, UDI 10381780268901; Product Code 3218, UDI 10381780268918; Product Code 3219, UDI 10381780268925; Product Code 3220, UDI 10381780268932; Product Code 3274, UDI 10381780268994; Product Code 3312, UDI 10381780269038; Product Code 3335, UDI 10381780269045; Product Code 3336, UDI 10381780269052; Product Code 3342, UDI 10381780269076; Product Code 3343, UDI 10381780269083; Product Code 3391, UDI 10381780269168; Product Code 3398, UDI 10381780269212; Product Code 3424, UDI 10381780269243; Product Code 3426, UDI 10381780269250; Product Code 3483, UDI 10381780269267; Product Code 3485, UDI 10381780269274; Product Code 3520, UDI 10381780282273; Product Code 3529, UDI 10381780269281; Product Code 3530, UDI 10381780269298; Product Code 3531, UDI 10381780269304; Product Code 3532, UDI 10381780269311; Product Code 3533, UDI 10381780269328; Product Code 3534, UDI 10381780269335; Product Code 3535, UDI 10381780269342; Product Code 3536, UDI 10381780269359; Product Code 3537, UDI 10381780269366; Product Code 3555, UDI 10381780269373; Product Code 3557, UDI 10381780269380; Product Code 3565, UDI 10381780269397; Product Code 3570, UDI 10381780269403; Product Code 3575, UDI 10381780269410; Product Code 3586, UDI 10381780269427; Product Code 3588, UDI 10381780269434; Product Code 3590, UDI 10381780269441; Product Code 3592, UDI 10381780269458; Product Code 3593, UDI 10381780269465; Product Code 3594, UDI 10381780269472; Product Code 3595, UDI 10381780269489; Product Code 3596, UDI 10381780269496; Product Code 3597, UDI 10381780269502; Product Code 3601, UDI 10381780269519; Product Code 3602, UDI 10381780269526; Product Code 3603, UDI 10381780269533; Product Code 3604, UDI 10381780269540; Product Code 3605, UDI 10381780269557; Product Code 3610, UDI 10381780269564; Product Code 3614, UDI 10381780269571; Product Code 3616, UDI 10381780269588; Product Code 3618, UDI 10381780269595; Product Code 3620, UDI 10381780269601; Product Code 3622, UDI 10381780269618; Product Code 3623, UDI 10381780269625; Product Code 3624, UDI 10381780269632; Product Code 3626, UDI 10381780269649; Product Code 3630, UDI 10381780269656; Product Code 3631, UDI 10381780269663; Product Code 3635, UDI 10381780269670; Product Code 3640, UDI 10381780269687; Product Code 3647, UDI 10381780269694; Product Code 3650, UDI 10381780269700; Product Code 3654, UDI 10381780202936¿; Product Code 3700, UDI 10381780269717; Product Code 3720, UDI 10381780269724; Product Code 3732, UDI 10381780269731; Product Code 3740, UDI 10381780269748; Product Code 3759, UDI 10381780269755; Product Code 3761, UDI 10381780269762; Product Code 3763, UDI 10381780269779; Product Code 3765, UDI 10381780269786; Product Code 3772, UDI 10381780269793; Product Code 3774, UDI 10381780269809; Product Code 3780, UDI 10381780269816; Product Code 3782, UDI 10381780269823; Product Code 3784, UDI 10381780269830; Product Code 3786, UDI 10381780269847; Product Code 3788, UDI 10381780269854; Product Code 3790, UDI 10381780269861; Product Code 3792, UDI 10381780269878; Product Code 3794, UDI 10381780269885; Product Code 3796, UDI 10381780269892; Product Code 3798, UDI 10381780269908; Product Code 3800, UDI 10381780269915; Product Code 3812, UDI 10381780269960; Product Code 3814, UDI 10381780269977; Product Code 3816, UDI 10381780269984; Product Code 3824, UDI 10381780270027; Product Code 3842, UDI 10381780270034; Product Code 3848, UDI 10381780270041; Product Code 3860, UDI 10381780270089; Product Code 3862, UDI 10381780270096; Product Code 3864, UDI 10381780270102; Product Code 3870, UDI 10381780270133; Product Code 3872, UDI 10381780270140; Product Code 3874, UDI 10381780270157; Product Code 3886, UDI 10381780270218; Product Code 3888, UDI 10381780270225; Product Code 3890, UDI 10381780270232; Product Code 3892, UDI 10381780270249; Product Code 3900, UDI 10381780270256; Product Code 3909, UDI 10381780270294; Product Code 3910, UDI 10381780270300; Product Code 3911, UDI 10381780270317; Product Code 3914, UDI 10381780270324; Product Code 3915, UDI 10381780270331; Product Code 3916, UDI 10381780270348; Product Code 3917, UDI 10381780270355; Product Code 3918, UDI 10381780270362; Product Code 3919, UDI 10381780270379; Product Code 3921, UDI 10381780270386; Product Code 3922, UDI 10381780270393; Product Code 3923, UDI 10381780270409; Product Code 3924, UDI 10381780270416; Product Code 3925, UDI 10381780270423; Product Code 3926, UDI 10381780270430; Product Code 3927, UDI 10381780270447; Product Code 3928, UDI 10381780270454; Product Code 3929, UDI 10381780270461; Product Code 3931, UDI 10381780270478; Product Code 3932, UDI 10381780270485; Product Code 3974, UDI 10381780270492; Product Code 3975, UDI 10381780270508; Product Code 3976, UDI 10381780270515; Product Code 3977, UDI 10381780270522; Product Code 3978, UDI 10381780270539; Product Code 3979, UDI 10381780270546; Product Code 3980, UDI 10381780270553; Product Code 3981, UDI 10381780270560; Product Code 3983, UDI 10381780270584; Product Code 4017, UDI 10381780270591; Product Code 4019, UDI 10381780270614; Product Code 4020, UDI 10381780270621; Product Code 4040, UDI 10381780270638; Product Code 4070, UDI 10381780270645; Product Code 4080, UDI 10381780270652; Product Code 4090, UDI 10381780270669; Product Code 4547, UDI 10381780270683; Product Code 4571, UDI 10381780270690; Product Code 4592, UDI 10381780270706; Product Code 4593, UDI 10381780270713; Product Code 4594, UDI 10381780270720; Product Code 4595, UDI 10381780270744; Product Code 4597, UDI 10381780270768; Product Code 4598, UDI 10381780270775; Product Code 4599, UDI 10381780270782; Product Code 4600, UDI 10381780270799; Product Code 4601, UDI 10381780270805; Product Code 4602, UDI 10381780270812; Product Code 4604, UDI 10381780270836; Product Code 4605, UDI 10381780270843; Product Code 4606, UDI 10381780270850; Product Code 4607, UDI 10381780270867; Product Code 4621, UDI 10381780270881; Product Code 4622, UDI 10381780270898; Product Code 4637, UDI 10381780270904; Product Code 4920, UDI 10381780270911; Product Code 4921, UDI 10381780270928; Product Code 4922, UDI 10381780270935; Product Code 4927, UDI 10381780270942; Product Code 4928, UDI 10381780270959; Product Code 4929, UDI 10381780270966; Product Code 4931, UDI 10381780270973; Product Code 4932, UDI 10381780270980; Product Code 4933, UDI 10381780270997; Product Code 4935, UDI 10381780271000; Product Code 4936, UDI 10381780271017; Product Code 4937, UDI 10381780271024; Product Code 4940, UDI 10381780271031; Product Code 4943, UDI 10381780271048; Product Code 4944, UDI 10381780271055; Product Code 4950, UDI 10381780268413; Product Code 4954, UDI 10381780271062; Product Code 4956, UDI 10381780271079; Product Code 4957, UDI 10381780271086; Product Code 4958, UDI 10381780271093; Product Code 4959, UDI 10381780271109; Product Code 4960, UDI 10381780271116; Product Code 4961, UDI 10381780271123; Product Code 4962, UDI 10381780271130; Product Code 4963, UDI 10381780271147; Product Code 4964, UDI 10381780271154; Product Code 4965, UDI 10381780271161; Product Code 4966, UDI 10381780271178; Product Code 4967, UDI 10381780271185; Product Code 4968, UDI 10381780271192; Product Code 4969, UDI 10381780271208; Product Code 4970, UDI 10381780271215; Product Code 4971, UDI 10381780271222; Product Code 4972, UDI 10381780271239; Product Code 4973, UDI 10381780271246; Product Code 4974, UDI 10381780271253; Product Code 4975, UDI 10381780271260; Product Code 4976, UDI 10381780271277; Product Code 4977, UDI 10381780271284; Product Code 4978, UDI 10381780271291; Product Code 4979, UDI 10381780271307; Product Code 4980, UDI 10381780271314; Product Code 4981, UDI 10381780271321; Product Code 4985, UDI 10381780271338; Product Code 4988, UDI 10381780271345; Product Code 10244, UDI 10381780271369; Product Code 10269, UDI 10381780271376; Product Code 10270, UDI 10381780271383; Product Code 10272, UDI 10381780268420; Product Code 10385, UDI 10381780271390; Product Code 10386, UDI 10381780271406; Product Code 10387, UDI 10381780271413; Product Code 10388, UDI 10381780271420; Product Code 10389, UDI 10381780271437; Product Code 10390, UDI 10381780271444; Product Code 10391, UDI 10381780271451; Product Code 10419, UDI 10381780271475; Product Code 10487, UDI 10381780271482; Product Code 10493, UDI 10381780271499; Product Code 10498, UDI 10381780271505; Product Code 10707, UDI 10381780271512; Product Code 10708, UDI 10381780271536; Product Code 10709, UDI 10381780271543; Product Code 11030, UDI 10381780271529; Product Code 11050, UDI 10381780271550; Product Code 11070, UDI 10381780271567; Product Code 11119, UDI 10381780271574; Product Code 11121, UDI 10381780271581; Product Code 11182, UDI 10381780268437; Product Code 11183, UDI 10381780268444; Product Code 11184, UDI 10381780271598; Product Code 11275, UDI 10381780271604; Product Code 11306, UDI 10381780271673; Product Code 11308, UDI 10381780271680; Product Code 11309, UDI 10381780271697; Product Code 11321, UDI 10381780271703; Product Code 11340, UDI 10381780271710; Product Code 11352, UDI 10381780271727; Product Code 11355, UDI 10381780271734; Product Code 11360, UDI 10381780271741; Product Code 11382, UDI 10381780271758; Product Code 11383, UDI 10381780271765; Product Code 11384, UDI 10381780271772; Product Code 11385, UDI 10381780271789; Product Code 11386, UDI 10381780271796; Product Code 11402, UDI 10381780271826; Product Code 11406, UDI 10381780271864; Product Code 11407, UDI 10381780271871; Product Code 11408, UDI 10381780271888; Product Code 11409, UDI 10381780271895; Product Code 11440, UDI 10381780271901; Product Code 11441, UDI 10381780271918; Product Code 11442, UDI 10381780271925; Product Code 11443, UDI 10381780271932; Product Code 11444, UDI 10381780271949; Product Code 11445, UDI 10381780271956; Product Code 11446, UDI 10381780271963; Product Code 11447, UDI 10381780271970; Product Code 11448, UDI 10381780271987; Product Code 11480, UDI 10381780271994; Product Code 11481, UDI 10381780272007; Product Code 11482, UDI 10381780272014; Product Code 11490, UDI 10381780272021; Product Code 11500, UDI 10381780272038; Product Code 11501, UDI 10381780272045; Product Code 11510, UDI 10381780272069; Product Code 11511, UDI 10381780272076; Product Code 11512, UDI 10381780272083; Product Code 11513, UDI 10381780272090; Product Code 11514, UDI 10381780272106; Product Code 11515, UDI 10381780272113; Product Code 11516, UDI 10381780272120; Product Code 11517, UDI 10381780272137; Product Code 11518, UDI 10381780272144; Product Code 11560, UDI 10381780272151; Product Code 11570, UDI 10381780272168; Product Code 11590, UDI 10381780272175; Product Code 11615, UDI 10381780272199; Product Code 11627, UDI 10381780272205; Product Code 11628, UDI 10381780272212; Product Code 11629, UDI 10381780272229; Product Code 11631, UDI 10381780272236; Product Code 11632, UDI 10381780272243; Product Code 11633, UDI 10381780272250; Product Code 11634, UDI 10381780272267; Product Code 11635, UDI 10381780272274; Product Code 11637, UDI 10381780272281; Product Code 11639, UDI 10381780272298; Product Code 11640, UDI 10381780272304; Product Code 11641, UDI 10381780272311; Product Code 11642, UDI 10381780272328; Product Code 11644, UDI 10381780272335; Product Code 11645, UDI 10381780272342; Product Code 11646, UDI 10381780272359; Product Code 11780, UDI 10381780272366; Product Code 11788, UDI 10381780272373; Product Code 11789, UDI 10381780272380; Product Code 11818, UDI 10381780272397; Product Code 11819, UDI 10381780399490; Product Code 11820, UDI 10381780272403; Product Code 11821, UDI 10381780272410; Product Code 11822, UDI 10381780272427; Product Code 11826, UDI 10381780272434; Product Code 11830, UDI 10381780272441; Product Code 11835, UDI 10381780272458; Product Code 11840, UDI 10381780272465; Product Code 11848, UDI 10381780272472; Product Code 11849, UDI 10381780272489; Product Code 11860, UDI 10381780282280; Product Code 11861, UDI 10381780272496; Product Code 11863, UDI 10381780272502; Product Code 11864, UDI 10381780272519; Product Code 11865, UDI 10381780272526; Product Code 11866, UDI 10381780272533; Product Code 11867, UDI 10381780272540; Product Code 11868, UDI 10381780272557; Product Code 11875, UDI 10381780272564; Product Code 11880, UDI 10381780272571; Product Code 11900, UDI 10381780272588; Product Code 11902, UDI 10381780272595; Product Code 11910, UDI 10381780272625; Product Code 11920, UDI 10381780272632; Product Code 11921, UDI 10381780272649; Product Code 11925, UDI 10381780272656; Product Code 11931, UDI 10381780272663; Product Code 11932, UDI 10381780272670; Product Code 11933, UDI 10381780272687; Product Code 11936, UDI 10381780272694; Product Code 11938, UDI 10381780272700; Product Code 11940, UDI 10381780272717; Product Code 11942, UDI 10381780272724; Product Code 11944, UDI 10381780272731; Product Code 11946, UDI 10381780272748; Product Code 11948, UDI 10381780272755; Product Code 11950, UDI 10381780272762; Product Code 11952, UDI 10381780272779; Product Code 11954, UDI 10381780272786; Product Code 11956, UDI 10381780272793; Product Code 11958, UDI 10381780272809; Product Code 11960, UDI 10381780272816; Product Code 11962, UDI 10381780272823; Product Code 11964, UDI 10381780272830; Product Code 11966, UDI 10381780272847; Product Code 11968, UDI 10381780272854; Product Code 10144R, UDI 10381780271352; Product Code 10405R, UDI 10381780271468; Product Code 11300R, UDI 10381780271611; Product Code 11301R, UDI 10381780271628; Product Code 11302R, UDI 10381780271635; Product Code 11303R, UDI 10381780271642; Product Code 11304R, UDI 10381780271659; Product Code 11305R, UDI 10381780271666; Product Code 11400R, UDI 10381780271802; Product Code 11401R, UDI 10381780271819; Product Code 11403R, UDI 10381780271833; Product Code 11404R, UDI 10381780271840; Product Code 11405R, UDI 10381780271857; Product Code 11502R, UDI 10381780272052; Product Code 11610R, UDI 10381780272182; Product Code 11904R, UDI 10381780272601; Product Code 11908R, UDI Not Available; Product Code 3030R, UDI 10381780268451; Product Code 3041R, UDI 10381780268475; Product Code 3044R, UDI 10381780282266; Product Code 3046R, UDI 10381780268482; Product Code 3053R, UDI 10381780268499; Product Code 3091R, UDI 10381780268543; Product Code 3094R, UDI 10381780268574; Product Code 3101R, UDI 10381780268611; Product Code 3103R, UDI 10381780268628; Product Code 3104R, UDI 10381780268635; Product Code 3105R, UDI 10381780268642; Product Code 3120R, UDI 10381780268659; Product Code 3121R, UDI 10381780268666; Product Code 3132R, UDI 10381780268673; Product Code 3138R, UDI 10381780268703; Product Code 3145R, UDI 10381780268727; Product Code 3147R, UDI 10381780268741; Product Code 3150R, UDI 10381780268765; Product Code 3151R, UDI 10381780268772; Product Code 3152R, UDI 10381780268789; Product Code 3167R, UDI 10381780268796; Product Code 3169R, UDI 10381780268802; Product Code 3175R, UDI 10381780268819; Product Code 3178R, UDI 10381780268840; Product Code 3187R, UDI 10381780268864; Product Code 3222R, UDI 10381780268949; Product Code 3223R, UDI 10381780268956; Product Code 3225R, UDI 10381780268963; Product Code 3259R, UDI 10381780268970; Product Code 3265R, UDI 10381780268987; Product Code 3279R, UDI 10381780269007; Product Code 3281R, UDI 10381780269014; Product Code 3311R, UDI 10381780269021; Product Code 3341R, UDI 10381780269069; Product Code 3361R, UDI 10381780269090; Product Code 3373R, UDI 10381780269106; Product Code 3374R, UDI 10381780269113; Product Code 3375R, UDI 10381780269120; Product Code 3376R, UDI 10381780269137; Product Code 3377R, UDI 10381780269144; Product Code 3379R, UDI 10381780269151; Product Code 3392R, UDI 10381780269175; Product Code 3393R, UDI 10381780269182; Product Code 3394R, UDI 10381780269199; Product Code 3397R, UDI 10381780269205; Product Code 3399R, UDI 10381780269229; Product Code 3422R, UDI 10381780269236; Product Code 3804R, UDI 10381780269922; Product Code 3806R, UDI 10381780269939; Product Code 3808R, UDI 10381780269946; Product Code 3810R, UDI 10381780269953; Product Code 3818R, UDI 10381780269991; Product Code 3820R, UDI 10381780270003; Product Code 3822R, UDI 10381780270010; Product Code 3854R, UDI 10381780270065; Product Code 3856R, UDI 10381780270058; Product Code 3858R, UDI 10381780270072; Product Code 3866R, UDI 10381780270119; Product Code 3868R, UDI 10381780270126; Product Code 3876R, UDI 10381780270164; Product Code 3878R, UDI 10381780270171; Product Code 3880R, UDI 10381780270188; Product Code 3882R, UDI 10381780270195; Product Code 3883R, UDI 10381780270201; Product Code 3906R, UDI 10381780270263; Product Code 3907R, UDI 10381780270270; Product Code 3908R, UDI 10381780270287; Product Code 3982R, UDI 10381780270577; Product Code 4018R, UDI 10381780270607; Product Code 4105R, UDI 10381780270676; Product Code 4596R, UDI 10381780270751; Product Code 4603R, UDI 10381780270829; Product Code 4615R, UDI 10381780270874; Product Code -80126,, UDI Not Available; Product Code -80127,, UDI Not Available; Product Code -80259,, UDI Not Available; Product Code -80263,, UDI 10381780511076; Product Code -80296,, UDI Not Available; Product Code -80585,, UDI Not Available; Product Code -8442,, UDI Not Available; Product Code -8836,, UDI Not Available; Product Code -8858,, UDI Not Available; Product Code -S11054,, UDI 10381780413394; Product Code 11908, UDI 10381780272618; Product Code 3577, UDI 10381780511090; Product Code 3582, UDI 10381780511106; Product Code 100-11513, UDI Not Available; Product Code 100-11515, UDI Not Available; Product Code 3876, UDI Not Available; Product Code 3883, UDI Not Available; Product Code 8222, UDI Not Available; Product Code 8296, UDI Not Available; Product Code 8442, UDI Not Available; Product Code 8652, UDI Not Available; Product Code 8741, UDI Not Available; Product Code 8742, UDI Not Available; Product Code 8762, UDI Not Available; Product Code 8836, UDI Not Available; Product Code 8858, UDI Not Available; Product Code 80126, UDI Not Available; Product Code 80127, UDI Not Available; Product Code 80146, UDI Not Available; Product Code 80172, UDI Not Available; Product Code 80174, UDI Not Available; Product Code 80259, UDI Not Available; Product Code 80263, UDI Not Available; Product Code 80296, UDI Not Available; Product Code 80346, UDI Not Available; Product Code 80369, UDI Not Available; Product Code 80370, UDI Not Available; Product Code 80398, UDI Not Available; Product Code 80410, UDI Not Available; Product Code 80474, UDI Not Available; Product Code 80567, UDI Not Available; Product Code 80579, UDI Not Available; Product Code 80581, UDI Not Available; Product Code 80582, UDI Not Available; Product Code 80583, UDI Not Available; Product Code 80584, UDI Not Available; Product Code 80585, UDI Not Available; Product Code 80586, UDI Not Available; Product Code 80587, UDI Not Available; Product Code 80590, UDI Not Available; Product Code 80081R, UDI Not Available; Product Code 80082R, UDI Not Available; Product Code 80222R, UDI Not Available; Product Code 80244R, UDI Not Available; Product Code 80245R, UDI Not Available; Product Code 80328R, UDI Not Available; Product Code CML_100-11275, UDI Not Available; Product Code CML_100-11440, UDI Not Available; Product Code CML_100-11441, UDI Not Available; Product Code CML_100-11442, UDI Not Available; Product Code CML_100-11444, UDI Not Available; Product Code CML_100-11447, UDI Not Available; Product Code CML_100-11448, UDI Not Available; Product Code CML_100-11480, UDI Not Available; Product Code CML_100-11490, UDI Not Available; Product Code CML_100-11644, UDI Not Available; Product Code CML_100-11645, UDI Not Available; Product Code CML_100-11646, UDI Not Available; Product Code CML_100-11826, UDI Not Available; Product Code CML_100-11848, UDI Not Available; Product Code CML_100-11875, UDI Not Available; Product Code CML_100-11908, UDI Not Available; Product Code CML_100-11910, UDI Not Available; Product Code CML_100-11940, UDI Not Available; Product Code CML_100-11960, UDI Not Available; Product Code CML_100-11964, UDI Not Available; Product Code CML_100-3424, UDI Not Available; Product Code OMN_10269, UDI Not Available; Product Code OMN_10270, UDI Not Available; Product Code OMN_10385, UDI Not Available; Product Code OMN_10386, UDI Not Available; Product Code OMN_10387, UDI Not Available; Product Code OMN_10388, UDI Not Available; Product Code OMN_10389, UDI Not Available; Product Code OMN_10390, UDI Not Available; Product Code OMN_10391, UDI Not Available; Product Code OMN_10405, UDI Not Available; Product Code OMN_10419, UDI Not Available; Product Code OMN_10707, UDI Not Available; Product Code OMN_10708, UDI Not Available; Product Code OMN_10709, UDI Not Available; Product Code OMN_11050, UDI Not Available; Product Code OMN_11121, UDI Not Available; Product Code OMN_11183, UDI Not Available; Product Code OMN_11184, UDI Not Available; Product Code OMN_11321, UDI Not Available; Product Code OMN_11481, UDI Not Available; Product Code OMN_11482, UDI Not Available; Product Code OMN_11510, UDI Not Available; Product Code OMN_11511, UDI Not Available; Product Code OMN_11512, UDI Not Available; Product Code OMN_11513, UDI Not Available; Product Code OMN_11514, UDI Not Available; Product Code OMN_11515, UDI Not Available; Product Code OMN_11516, UDI Not Available; Product Code OMN_11517, UDI Not Available; Product Code OMN_11518, UDI Not Available; Product Code OMN_11560, UDI Not Available; Product Code OMN_11640, UDI Not Available; Product Code OMN_3044, UDI Not Available; Product Code OMN_3069, UDI Not Available; Product Code OMN_3091, UDI Not Available; Product Code OMN_3094, UDI Not Available; Product Code OMN_3098, UDI Not Available; Product Code OMN_3099, UDI Not Available; Product Code OMN_3101, UDI Not Available; Product Code OMN_3105, UDI Not Available; Product Code OMN_3145, UDI Not Available; Product Code OMN_3187, UDI Not Available; Product Code OMN_3201, UDI Not Available; Product Code OMN_3222, UDI Not Available; Product Code OMN_3397, UDI Not Available; Product Code OMN_3422, UDI Not Available; Product Code OMN_3536, UDI Not Available; Product Code OMN_3586, UDI Not Available; Product Code OMN_3588, UDI Not Available; Product Code OMN_3590, UDI Not Available; Product Code OMN_3592, UDI Not Available; Product Code OMN_3593, UDI Not Available; Product Code OMN_3623, UDI Not Available; Product Code OMN_3626, UDI Not Available; Product Code OMN_3759, UDI Not Available; Product Code OMN_3772, UDI Not Available; Product Code OMN_3774, UDI Not Available; Product Code OMN_3792, UDI Not Available; Product Code OMN_3794, UDI Not Available; Product Code OMN_3796, UDI Not Available; Product Code OMN_3798, UDI Not Available; Product Code OMN_3854, UDI Not Available; Product Code OMN_3864, UDI Not Available; Product Code OMN_3868, UDI Not Available; Product Code OMN_3872, UDI Not Available; Product Code OMN_3888, UDI Not Available; Product Code OMN_3909, UDI Not Available; Product Code OMN_3911, UDI Not Available; Product Code OMN_3974, UDI Not Available; Product Code OMN_3975, UDI Not Available; Product Code OMN_3976, UDI Not Available; Product Code OMN_3977, UDI Not Available; Product Code OMN_3978, UDI Not Available; Product Code OMN_3980, UDI Not Available; Product Code OMN_3981, UDI Not Available; Product Code OMN_3983, UDI Not Available; Product Code OMN_4019, UDI Not Available; Product Code OMN_4070, UDI Not Available; Product Code OMN_4090, UDI Not Available; Product Code OMN_4547, UDI Not Available; Product Code OMN_4920, UDI Not Available; Product Code OMN_4921, UDI Not Available; Product Code OMN_4922, UDI Not Available; Product Code OMN_4927, UDI Not Available; Product Code OMN_4928, UDI Not Available; Product Code OMN_4929, UDI Not Available; Product Code OMN_4940, UDI Not Available; Product Code OMN_4943, UDI Not Available; Product Code OMN_4957, UDI Not Available; Product Code OMN_4958, UDI Not Available; Product Code OMN_4961, UDI Not Available; Product Code OMN_4962, UDI Not Available; Product Code OMN_4963, UDI Not Available; Product Code OMN_4964, UDI Not Available; Product Code OMN_4965, UDI Not Available; Product Code OMN_4967, UDI Not Available; Product Code OMN_4968, UDI Not Available; Product Code OMN_4969, UDI Not Available; Product Code OMN_4970, UDI Not Available; Product Code OMN_4971, UDI Not Available; Product Code OMN_4972, UDI Not Available; Product Code OMN_4973, UDI Not Available; Product Code OMN_4974, UDI Not Available; Product Code OMN_4978, UDI Not Available; Product Code OMN_4979, UDI Not Available; Product Code OMN_4980, UDI Not Available; Product Code OMN_4981, UDI Not Available.
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp. (NeuroSciences); 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Mary O'Neill; 0-640-8679411
• Manufacturer Reason for Recall: The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
• FDA Determined Cause: Labeling design
• Action: Integra issued an URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice to its consignees on 06/05/2026 via overnight mail. The notice explained the issue, hazards and risks, and requested the following: "Customer/Medical Facility-Actions to Take: 1. If your facility has validated its own sterilization process, it is in your discretion to follow your validated process recognizing that Integra LifeSciences has only validated the sterilization process noted below. 2. If utilizing the Gravity Sterilization Method, stop using this method immediately. The Gravity Sterilization Method for sterilizing Omni-Tract devices is not effective. 3. Replace the instructions in the current IFUs (40-9015 Rev BAA and 40-6008 Rev AAA) for 'sterilization' sections with the following: Sterilization Following proper cleaning and prior to sterilization, use an appropriate sterilization wrap with sterilization tray to ensure that components and devices are not damaged in transportation to and from the sterilizer. NOTE: Validation was completed using a wrapped sterilization tray and not a rigid container. Steam Sterilization Method: Process Validation procedures followed ANSI/AAMI ST79 standards for Prevacuum. Steam Sterilization is the validated method for sterilizing Omni-Tract products in a wrapped tray. No other methods have been validated and approved for use with Omni-Tract products. NOTE: Instruments, regardless of sterilization cycle used, will remain too hot for immediate use. Allow sufficient dry time and cooling before use. Prevacuum: Utilize one of the Prevacuum sterilization cycles listed in Table 2 to ensure the Omni-Tract Surgical Retractor Systems are properly sterilized after use. Table 2: Prevacuum Sterilization Cycle Parameters Cycle Type Temperature Exposure Time Dry Time (minimum) Prevacuum 270F (132C) 4 minutes 90 minutes Prevacuum 273F (134C) 3 minutes 110 minutes Prevacuum 273F (134C) 18 minutes 120 minutes 4. Complete the Acknowledgement Form included in Ap
• Quantity in Commerce: 633 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea (the Republic of), Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands (the), New Zealand, Norway, Pakistan, Palestine, State of, Philippines (the), Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, R¿union, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Thailand, Trinidad and Tobago, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland, (the), Viet Nam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.