Recall
FDAHealthApril 10, 2026

Stryker Sustainability Solutions — CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

⚠️ Incomplete seals on sterile product

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 10, 2026

US Nationwide and the countries of Israel and Canada.

What's affected?

Product
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Lot code
2934107

Additional details

UDI 07613327357301, Lot Numbers: 2934107, 3695884, 3813841, 3963557, 4293648, 4660245, 4816422, 4937844, 4984006, 5024442, 2964378, 3695885, 3813842, 3963558, 4294641, 4665924, 4816423, 4937846, 4984751, 5024443, 3369649, 3695886, 3813843, 3963559, 4320451, 4665926, 4820652, 4937850, 4985810, 5025866, 3414030, 3695889, 3813844, 3963561, 4320454, 4677505, 4824140, 4937853, 4985813, 5025908, 3487957, 3695898, 3814084, 3963565, 4320584, 4683574, 4824141, 4937876, 4985814, 5025909, 3487959, 3695899, 3814089, 3963923, 4320585, 4690460, 4824142, 4937886, 4985819, 5025913, 3516565, 3695905, 3814090, 3965856, 4352366, 4690461, 4824143, 4937914, 4985820, 5030283, 3516579, 3695909, 3814151, 3971195, 4365471, 4722597, 4824144, 4937921, 4985977, 5030284, 3533495, 3695911, 3814152, 3971196, 4365472, 4722598, 4825584, 4937937, 4985978, 5030285, 3536146, 3695912, 3814379, 3971197, 4371818, 4734903, 4825590, 4938070, 4985980, 5030306, 3563129, 3713425, 3814402, 3971199, 4380641, 4742839, 4828929, 4938075, 4986540, 5030308, 3623660, 3720912, 3814403, 3971200, 4384663, 4770976, 4829405, 4940572, 4990713, 5030309, 3635399, 3720913, 3814404, 3971363, 4384664, 4770977, 4829407, 4940573, 4990727, 5034157, 3639136, 3720914, 3814405, 3991716, 4384665, 4774463, 4829408, 4940574, 4992829, 5034251, 3642928, 3720915, 3814406, 4000629, 4384666, 4774464, 4829409, 4940575, 4998446, 5036560, 3657002, 3720916, 3814407, 4018409, 4384667, 4776002, 4830745, 4952872, 4998448, 5036561, 3657003, 3720919, 3814408, 4020134, 4384668, 4776023, 4830748, 4953149, 4998547, 5040068, 3658634, 3733771, 3814409, 4068043, 4390632, 4799861, 4833289, 4953150, 4998548, 5041755, 3658673, 3741542, 3814410, 4111059, 4400780, 4799862, 4840236, 4953151, 5002404, 5041756, 3659104, 3743987, 3824661, 4115291, 4406069, 4799863, 4841977, 4953153, 5002405, 5041760, 3665462, 3748109, 3824662, 4142838, 4423866, 4800152, 4841978, 4953154, 5002602, 5043056, 3665463, 3766803, 3831087, 4142840, 4423870, 4800155, 4842198, 4953155, 5002603, 5043824, 3665464, 3766807, 3841170, 4142841, 4428699, 4800353, 4842783, 4953156, 5002604, 5043825, 3665465, 3766808, 3843536, 4144673, 4428700, 4801216, 4846033, 4953157, 5002605, 5052577, 3665466, 3770489, 3845330, 4144997, 4438106, 4806963, 4852908, 4953162, 5008310, 5059783, 3670655, 3774007, 3851621, 4181100, 4450156, 4806964, 4854158, 4953183, 5008392, 5059784, 3670656, 3778766, 3851622, 4181101, 4495768, 4806965, 4855585, 4953184, 5008394, 5059785, 3670659, 3778767, 3851623, 4181102, 4498972, 4806966, 4855586, 4960862, 5008412, 5059786, 3670662, 3778769, 3851624, 4199249, 4500710, 4808371, 4855669, 4973101, 5008704, 5059787, 3670665, 3788271, 3851625, 4200117, 4512636, 4811617, 4859421, 4973653, 5008705, 5059788, 3670666, 3792023, 3851626, 4218160, 4519621, 4813305, 4859422, 4978434, 5008750, 5059789, 3684410, 3805982, 3888520, 4225232, 4548019, 4813306, 4865886, 4978435, 5008751, 5067006, 3684411, 3809170, 3888521, 4232774, 4593743, 4813307, 4868858, 4979809, 5017528, 5078231, 3684412, 3809184, 3888524, 4265339, 4617777, 4813310, 4871606, 4979810, 5017529, 5078232, 3691269, 3809306, 3895233, 4265852, 4623978, 4813611, 4871607, 4980427, 5017533, 5081439, 3693634, 3809307, 3944996, 4281497, 4636786, 4813612, 4871608, 4980429, 5017536, 5081440, 3695835, 3811477, 3944997, 4281516, 4637499, 4814211, 4871609, 4980430, 5017539, 5081441, 3695836, 3811480, 3944998, 4281899, 4643511, 4814213, 4871610, 4980836, 5017541, 5083240, 3695850, 3813705, 3953668, 4282025, 4651653, 4814221, 4872209, 4980837, 5021604, 5083242, 3695852, 3813706, 3960483, 4282026, 4653186, 4814228, 4937761, 4980838, 5021606, 5085978, 3695865, 3813707, 3963551, 4282027, 4655459, 4814231, 4937764, 4980870, 5021607, 3695866, 3813708, 3963553, 4282248, 4656625, 4816416, 4937771, 4982864, 5022826, 3695873, 3813709, 3963555, 4282965, 4659207, 4816418, 4937832, 4984004, 5024439, 3695876, 3813839, 3963556, 4292165, 4659209, 4816419, 4937843, 4984005, 5024440.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 449 units.

View original FDA notice →

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