{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221034", "product_res_number": "Z-2714-2026", "event_date_initiated": "2026-06-05", "event_date_posted": "2026-07-09", "recall_status": "Open, Classified", "res_event_number": "99193", "product_code": "GAD", "product_description": "OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.", "code_info": "Product Code 3032, UDI 10381780268468; \nProduct Code 3055, UDI 10381780268505; \nProduct Code 3069, UDI 10381780268512; \nProduct Code 3076, UDI 10381780268529; \nProduct Code 3086, UDI 10381780268536; \nProduct Code 3092, UDI 10381780268550; \nProduct Code 3093, UDI 10381780268567; \nProduct Code 3096, UDI 10381780268581; \nProduct Code 3098, UDI 10381780268598; \nProduct Code 3099, UDI 10381780268604; \nProduct Code 3133, UDI 10381780268680; \nProduct Code 3137, UDI 10381780268697; \nProduct Code 3142, UDI 10381780268710; \nProduct Code 3146, UDI 10381780268734; \nProduct Code 3148, UDI 10381780268758; \nProduct Code 3176, UDI 10381780268826; \nProduct Code 3177, UDI 10381780268833; \nProduct Code 3185, UDI 10381780268857; \nProduct Code 3201, UDI 10381780268871; \nProduct Code 3203, UDI 10381780268888; \nProduct Code 3216, UDI 10381780268895; \nProduct Code 3217, UDI 10381780268901; \nProduct Code 3218, UDI 10381780268918; \nProduct Code 3219, UDI 10381780268925; \nProduct Code 3220, UDI 10381780268932; \nProduct Code 3274, UDI 10381780268994; \nProduct Code 3312, UDI 10381780269038; \nProduct Code 3335, UDI 10381780269045; \nProduct Code 3336, UDI 10381780269052; \nProduct Code 3342, UDI 10381780269076; \nProduct Code 3343, UDI 10381780269083; \nProduct Code 3391, UDI 10381780269168; \nProduct Code 3398, UDI 10381780269212; \nProduct Code 3424, UDI 10381780269243; \nProduct Code 3426, UDI 10381780269250; \nProduct Code 3483, UDI 10381780269267; \nProduct Code 3485, UDI 10381780269274; \nProduct Code 3520, UDI 10381780282273; \nProduct Code 3529, UDI 10381780269281; \nProduct Code 3530, UDI 10381780269298; \nProduct Code 3531, UDI 10381780269304; \nProduct Code 3532, UDI 10381780269311; \nProduct Code 3533, UDI 10381780269328; \nProduct Code 3534, UDI 10381780269335; \nProduct Code 3535, UDI 10381780269342; \nProduct Code 3536, UDI 10381780269359; \nProduct Code 3537, UDI 10381780269366; \nProduct Code 3555, UDI 10381780269373; \nProduct Code 3557, UDI 10381780269380; \nProduct Code 3565, UDI 10381780269397; \nProduct Code 3570, UDI 10381780269403; \nProduct Code 3575, UDI 10381780269410; \nProduct Code 3586, UDI 10381780269427; \nProduct Code 3588, UDI 10381780269434; \nProduct Code 3590, UDI 10381780269441; \nProduct Code 3592, UDI 10381780269458; \nProduct Code 3593, UDI 10381780269465; \nProduct Code 3594, UDI 10381780269472; \nProduct Code 3595, UDI 10381780269489; \nProduct Code 3596, UDI 10381780269496; \nProduct Code 3597, UDI 10381780269502; \nProduct Code 3601, UDI 10381780269519; \nProduct Code 3602, UDI 10381780269526; \nProduct Code 3603, UDI 10381780269533; \nProduct Code 3604, UDI 10381780269540; \nProduct Code 3605, UDI 10381780269557; \nProduct Code 3610, UDI 10381780269564; \nProduct Code 3614, UDI 10381780269571; \nProduct Code 3616, UDI 10381780269588; \nProduct Code 3618, UDI 10381780269595; \nProduct Code 3620, UDI 10381780269601; \nProduct Code 3622, UDI 10381780269618; \nProduct Code 3623, UDI 10381780269625; \nProduct Code 3624, UDI 10381780269632; \nProduct Code 3626, UDI 10381780269649; \nProduct Code 3630, UDI 10381780269656; \nProduct Code 3631, UDI 10381780269663; \nProduct Code 3635, UDI 10381780269670; \nProduct Code 3640, UDI 10381780269687; \nProduct Code 3647, UDI 10381780269694; \nProduct Code 3650, UDI 10381780269700; \nProduct Code 3654, UDI 10381780202936¿; \nProduct Code 3700, UDI 10381780269717; \nProduct Code 3720, UDI 10381780269724; \nProduct Code 3732, UDI 10381780269731; \nProduct Code 3740, UDI 10381780269748; \nProduct Code 3759, UDI 10381780269755; \nProduct Code 3761, UDI 10381780269762; \nProduct Code 3763, UDI 10381780269779; \nProduct Code 3765, UDI 10381780269786; \nProduct Code 3772, UDI 10381780269793; \nProduct Code 3774, UDI 10381780269809; \nProduct Code 3780, UDI 10381780269816; \nProduct Code 3782, UDI 10381780269823; \nProduct Code 3784, UDI 10381780269830; \nProduct Code 3786, UDI 10381780269847; \nProduct Code 3788, UDI 10381780269854; \nProduct Code 3790, UDI 10381780269861; \nProduct Code 3792, UDI 10381780269878; \nProduct Code 3794, UDI 10381780269885; \nProduct Code 3796, UDI 10381780269892; \nProduct Code 3798, UDI 10381780269908; \nProduct Code 3800, UDI 10381780269915; \nProduct Code 3812, UDI 10381780269960; \nProduct Code 3814, UDI 10381780269977; \nProduct Code 3816, UDI 10381780269984; \nProduct Code 3824, UDI 10381780270027; \nProduct Code 3842, UDI 10381780270034; \nProduct Code 3848, UDI 10381780270041; \nProduct Code 3860, UDI 10381780270089; \nProduct Code 3862, UDI 10381780270096; \nProduct Code 3864, UDI 10381780270102; \nProduct Code 3870, UDI 10381780270133; \nProduct Code 3872, UDI 10381780270140; \nProduct Code 3874, UDI 10381780270157; \nProduct Code 3886, UDI 10381780270218; \nProduct Code 3888, UDI 10381780270225; \nProduct Code 3890, UDI 10381780270232; \nProduct Code 3892, UDI 10381780270249; \nProduct Code 3900, UDI 10381780270256; \nProduct Code 3909, UDI 10381780270294; \nProduct Code 3910, UDI 10381780270300; \nProduct Code 3911, UDI 10381780270317; \nProduct Code 3914, UDI 10381780270324; \nProduct Code 3915, UDI 10381780270331; \nProduct Code 3916, UDI 10381780270348; \nProduct Code 3917, UDI 10381780270355; \nProduct Code 3918, UDI 10381780270362; \nProduct Code 3919, UDI 10381780270379; \nProduct Code 3921, UDI 10381780270386; \nProduct Code 3922, UDI 10381780270393; \nProduct Code 3923, UDI 10381780270409; \nProduct Code 3924, UDI 10381780270416; \nProduct Code 3925, UDI 10381780270423; \nProduct Code 3926, UDI 10381780270430; 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\nProduct Code 4936, UDI 10381780271017; \nProduct Code 4937, UDI 10381780271024; \nProduct Code 4940, UDI 10381780271031; \nProduct Code 4943, UDI 10381780271048; \nProduct Code 4944, UDI 10381780271055; \nProduct Code 4950, UDI 10381780268413; \nProduct Code 4954, UDI 10381780271062; \nProduct Code 4956, UDI 10381780271079; \nProduct Code 4957, UDI 10381780271086; \nProduct Code 4958, UDI 10381780271093; \nProduct Code 4959, UDI 10381780271109; \nProduct Code 4960, UDI 10381780271116; \nProduct Code 4961, UDI 10381780271123; \nProduct Code 4962, UDI 10381780271130; \nProduct Code 4963, UDI 10381780271147; \nProduct Code 4964, UDI 10381780271154; \nProduct Code 4965, UDI 10381780271161; \nProduct Code 4966, UDI 10381780271178; \nProduct Code 4967, UDI 10381780271185; \nProduct Code 4968, UDI 10381780271192; \nProduct Code 4969, UDI 10381780271208; \nProduct Code 4970, UDI 10381780271215; \nProduct Code 4971, UDI 10381780271222; \nProduct Code 4972, UDI 10381780271239; \nProduct Code 4973, UDI 10381780271246; \nProduct Code 4974, UDI 10381780271253; \nProduct Code 4975, UDI 10381780271260; \nProduct Code 4976, UDI 10381780271277; \nProduct Code 4977, UDI 10381780271284; \nProduct Code 4978, UDI 10381780271291; \nProduct Code 4979, UDI 10381780271307; \nProduct Code 4980, UDI 10381780271314; \nProduct Code 4981, UDI 10381780271321; \nProduct Code 4985, UDI 10381780271338; \nProduct Code 4988, UDI 10381780271345; \nProduct Code 10244, UDI 10381780271369; \nProduct Code 10269, UDI 10381780271376; \nProduct Code 10270, UDI 10381780271383; \nProduct Code 10272, UDI 10381780268420; \nProduct Code 10385, UDI 10381780271390; \nProduct Code 10386, UDI 10381780271406; \nProduct Code 10387, UDI 10381780271413; \nProduct Code 10388, UDI 10381780271420; \nProduct Code 10389, UDI 10381780271437; \nProduct Code 10390, UDI 10381780271444; \nProduct Code 10391, UDI 10381780271451; \nProduct Code 10419, UDI 10381780271475; \nProduct Code 10487, UDI 10381780271482; \nProduct Code 10493, UDI 10381780271499; \nProduct Code 10498, UDI 10381780271505; \nProduct Code 10707, UDI 10381780271512; \nProduct Code 10708, UDI 10381780271536; \nProduct Code 10709, UDI 10381780271543; \nProduct Code 11030, UDI 10381780271529; \nProduct Code 11050, UDI 10381780271550; \nProduct Code 11070, UDI 10381780271567; \nProduct Code 11119, UDI 10381780271574; \nProduct Code 11121, UDI 10381780271581; \nProduct Code 11182, UDI 10381780268437; \nProduct Code 11183, UDI 10381780268444; \nProduct Code 11184, UDI 10381780271598; \nProduct Code 11275, UDI 10381780271604; \nProduct Code 11306, UDI 10381780271673; \nProduct Code 11308, UDI 10381780271680; \nProduct Code 11309, UDI 10381780271697; \nProduct Code 11321, UDI 10381780271703; \nProduct Code 11340, UDI 10381780271710; \nProduct Code 11352, UDI 10381780271727; \nProduct Code 11355, UDI 10381780271734; \nProduct Code 11360, UDI 10381780271741; \nProduct Code 11382, UDI 10381780271758; \nProduct Code 11383, UDI 10381780271765; \nProduct Code 11384, UDI 10381780271772; \nProduct Code 11385, UDI 10381780271789; \nProduct Code 11386, UDI 10381780271796; \nProduct Code 11402, UDI 10381780271826; \nProduct Code 11406, UDI 10381780271864; \nProduct Code 11407, UDI 10381780271871; \nProduct Code 11408, UDI 10381780271888; \nProduct Code 11409, UDI 10381780271895; \nProduct Code 11440, UDI 10381780271901; \nProduct Code 11441, UDI 10381780271918; \nProduct Code 11442, UDI 10381780271925; \nProduct Code 11443, UDI 10381780271932; \nProduct Code 11444, UDI 10381780271949; \nProduct Code 11445, UDI 10381780271956; \nProduct Code 11446, UDI 10381780271963; \nProduct Code 11447, UDI 10381780271970; \nProduct Code 11448, UDI 10381780271987; \nProduct Code 11480, UDI 10381780271994; \nProduct Code 11481, UDI 10381780272007; \nProduct Code 11482, UDI 10381780272014; \nProduct Code 11490, UDI 10381780272021; \nProduct Code 11500, UDI 10381780272038; \nProduct Code 11501, UDI 10381780272045; \nProduct Code 11510, UDI 10381780272069; \nProduct Code 11511, UDI 10381780272076; \nProduct Code 11512, UDI 10381780272083; \nProduct Code 11513, UDI 10381780272090; \nProduct Code 11514, UDI 10381780272106; \nProduct Code 11515, UDI 10381780272113; \nProduct Code 11516, UDI 10381780272120; \nProduct Code 11517, UDI 10381780272137; \nProduct Code 11518, UDI 10381780272144; \nProduct Code 11560, UDI 10381780272151; \nProduct Code 11570, UDI 10381780272168; \nProduct Code 11590, UDI 10381780272175; \nProduct Code 11615, UDI 10381780272199; \nProduct Code 11627, UDI 10381780272205; \nProduct Code 11628, UDI 10381780272212; \nProduct Code 11629, UDI 10381780272229; \nProduct Code 11631, UDI 10381780272236; \nProduct Code 11632, UDI 10381780272243; \nProduct Code 11633, UDI 10381780272250; \nProduct Code 11634, UDI 10381780272267; \nProduct Code 11635, UDI 10381780272274; \nProduct Code 11637, UDI 10381780272281; \nProduct Code 11639, UDI 10381780272298; \nProduct Code 11640, UDI 10381780272304; \nProduct Code 11641, UDI 10381780272311; \nProduct Code 11642, UDI 10381780272328; \nProduct Code 11644, UDI 10381780272335; \nProduct Code 11645, UDI 10381780272342; \nProduct Code 11646, UDI 10381780272359; \nProduct Code 11780, UDI 10381780272366; \nProduct Code 11788, UDI 10381780272373; \nProduct Code 11789, UDI 10381780272380; \nProduct Code 11818, UDI 10381780272397; \nProduct Code 11819, UDI 10381780399490; \nProduct Code 11820, UDI 10381780272403; \nProduct Code 11821, UDI 10381780272410; \nProduct Code 11822, UDI 10381780272427; \nProduct Code 11826, UDI 10381780272434; \nProduct Code 11830, UDI 10381780272441; \nProduct Code 11835, UDI 10381780272458; \nProduct Code 11840, UDI 10381780272465; \nProduct Code 11848, UDI 10381780272472; \nProduct Code 11849, UDI 10381780272489; \nProduct Code 11860, UDI 10381780282280; \nProduct Code 11861, UDI 10381780272496; \nProduct Code 11863, UDI 10381780272502; \nProduct Code 11864, UDI 10381780272519; \nProduct Code 11865, UDI 10381780272526; \nProduct Code 11866, UDI 10381780272533; \nProduct Code 11867, UDI 10381780272540; \nProduct Code 11868, UDI 10381780272557; \nProduct Code 11875, UDI 10381780272564; \nProduct Code 11880, UDI 10381780272571; \nProduct Code 11900, UDI 10381780272588; \nProduct Code 11902, UDI 10381780272595; \nProduct Code 11910, UDI 10381780272625; \nProduct Code 11920, UDI 10381780272632; \nProduct Code 11921, UDI 10381780272649; \nProduct Code 11925, UDI 10381780272656; \nProduct Code 11931, UDI 10381780272663; \nProduct Code 11932, UDI 10381780272670; \nProduct Code 11933, UDI 10381780272687; \nProduct Code 11936, UDI 10381780272694; \nProduct Code 11938, UDI 10381780272700; \nProduct Code 11940, UDI 10381780272717; \nProduct Code 11942, UDI 10381780272724; \nProduct Code 11944, UDI 10381780272731; \nProduct Code 11946, UDI 10381780272748; \nProduct Code 11948, UDI 10381780272755; \nProduct Code 11950, UDI 10381780272762; \nProduct Code 11952, UDI 10381780272779; \nProduct Code 11954, UDI 10381780272786; \nProduct Code 11956, UDI 10381780272793; \nProduct Code 11958, UDI 10381780272809; \nProduct Code 11960, UDI 10381780272816; \nProduct Code 11962, UDI 10381780272823; \nProduct Code 11964, UDI 10381780272830; \nProduct Code 11966, UDI 10381780272847; \nProduct Code 11968, UDI 10381780272854; \nProduct Code 10144R, UDI 10381780271352; \nProduct Code 10405R, UDI 10381780271468; \nProduct Code 11300R, UDI 10381780271611; \nProduct Code 11301R, UDI 10381780271628; \nProduct Code 11302R, UDI 10381780271635; \nProduct Code 11303R, UDI 10381780271642; \nProduct Code 11304R, UDI 10381780271659; \nProduct Code 11305R, UDI 10381780271666; \nProduct Code 11400R, UDI 10381780271802; \nProduct Code 11401R, UDI 10381780271819; \nProduct Code 11403R, UDI 10381780271833; \nProduct Code 11404R, UDI 10381780271840; \nProduct Code 11405R, UDI 10381780271857; \nProduct Code 11502R, UDI 10381780272052; \nProduct Code 11610R, UDI 10381780272182; \nProduct Code 11904R, UDI 10381780272601; \nProduct Code 11908R, UDI Not Available; \nProduct Code 3030R, UDI 10381780268451; \nProduct Code 3041R, UDI 10381780268475; \nProduct Code 3044R, UDI 10381780282266; \nProduct Code 3046R, UDI 10381780268482; \nProduct Code 3053R, UDI 10381780268499; \nProduct Code 3091R, UDI 10381780268543; \nProduct Code 3094R, UDI 10381780268574; \nProduct Code 3101R, UDI 10381780268611; \nProduct Code 3103R, UDI 10381780268628; \nProduct Code 3104R, UDI 10381780268635; \nProduct Code 3105R, UDI 10381780268642; \nProduct Code 3120R, UDI 10381780268659; \nProduct Code 3121R, UDI 10381780268666; \nProduct Code 3132R, UDI 10381780268673; \nProduct Code 3138R, UDI 10381780268703; \nProduct Code 3145R, UDI 10381780268727; \nProduct Code 3147R, UDI 10381780268741; \nProduct Code 3150R, UDI 10381780268765; \nProduct Code 3151R, UDI 10381780268772; \nProduct Code 3152R, UDI 10381780268789; \nProduct Code 3167R, UDI 10381780268796; \nProduct Code 3169R, UDI 10381780268802; \nProduct Code 3175R, UDI 10381780268819; \nProduct Code 3178R, UDI 10381780268840; \nProduct Code 3187R, UDI 10381780268864; \nProduct Code 3222R, UDI 10381780268949; \nProduct Code 3223R, UDI 10381780268956; 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\nProduct Code OMN_4943, UDI Not Available; \nProduct Code OMN_4957, UDI Not Available; \nProduct Code OMN_4958, UDI Not Available; \nProduct Code OMN_4961, UDI Not Available; \nProduct Code OMN_4962, UDI Not Available; \nProduct Code OMN_4963, UDI Not Available; \nProduct Code OMN_4964, UDI Not Available; \nProduct Code OMN_4965, UDI Not Available; \nProduct Code OMN_4967, UDI Not Available; \nProduct Code OMN_4968, UDI Not Available; \nProduct Code OMN_4969, UDI Not Available; \nProduct Code OMN_4970, UDI Not Available; \nProduct Code OMN_4971, UDI Not Available; \nProduct Code OMN_4972, UDI Not Available; \nProduct Code OMN_4973, UDI Not Available; \nProduct Code OMN_4974, UDI Not Available; \nProduct Code OMN_4978, UDI Not Available; \nProduct Code OMN_4979, UDI Not Available; \nProduct Code OMN_4980, UDI Not Available; \nProduct Code OMN_4981, UDI Not Available.", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp. (NeuroSciences)", "address_1": "1100 Campus Rd", "city": "Princeton", "state": "NJ", "postal_code": "08540-6650", "additional_info_contact": "Mary O'Neill\n0-640-8679411", "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.", "root_cause_description": "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: \n\"Customer/Medical Facility-Actions to Take:\n1. 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.\n2. If utilizing the Gravity Sterilization Method, stop using this method immediately. The Gravity Sterilization Method for sterilizing Omni-Tract devices is not effective.\n3. Replace the instructions in the current IFUs (40-9015 Rev BAA and 40-6008 Rev AAA) for 'sterilization' sections with the following:\nSterilization\nFollowing 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.\nNOTE: Validation was completed using a wrapped sterilization tray and not a rigid container.\nSteam Sterilization Method:\nProcess Validation procedures followed ANSI/AAMI ST79 standards for Prevacuum.\nSteam Sterilization is the validated method for sterilizing Omni-Tract products in a wrapped tray. \nNo other methods have been validated and approved for use with Omni-Tract products. \nNOTE: Instruments, regardless of sterilization cycle used, will remain too hot for immediate use. Allow sufficient dry time and cooling before use.\nPrevacuum:\nUtilize one of the Prevacuum sterilization cycles listed in Table 2 to ensure the Omni-Tract Surgical Retractor Systems are properly sterilized after use.\nTable 2: Prevacuum Sterilization Cycle Parameters Cycle Type Temperature Exposure Time Dry Time (minimum)\nPrevacuum\n270F (132C)\n4 minutes\n90 minutes\nPrevacuum\n273F (134C)\n3 minutes\n110 minutes\nPrevacuum\n273F (134C)\n18 minutes\n120 minutes\n4. Complete the Acknowledgement Form included in Ap", "product_quantity": "633 units", "distribution_pattern": "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.", "openfda": { "k_number": [ "K781445", "K843216", "K830585", "K930316", 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