Recall archive / FDA device enforcement

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. — FDA record Z-2714-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 5, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Reason: 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.
Classification: Class II
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Quantity: 633 units
Agency-reported status: Ongoing
Source record identifier: Z-2714-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 116...

Label field

Details supplied by the agency

Lot, code or applicability

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 116...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 15, 2026
Recall initiation date: Jun 5, 2026
Center classification date: Jul 9, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records