Class IIOngoingZ-2714-2026
Integra LifeSciences Corp. (NeuroSciences) recalls OmniTract Surgical Retractor System
Integra LifeSciences Corp. (NeuroSciences)Princeton, NJ, United StatesReported Jul 15, 2026 · 7 days ago
Legal News Analyst ·
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Lot / code information
- 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
- t 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
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- t Available; Product Code CML_100-3424
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- t Available; Product Code OMN_10269
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Show 623 more code fieldsShow fewer
What the firm is doing
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
DistributionShow detailsHide
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.
Class IIWhat this means
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2714-2026
- FDA device classification · GADOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus
Legal News Analyst
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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