CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Enforcement
- Recall Number
- Z-2184-2026
- Event ID
- 98708
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Sustainability Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- May 20, 2026
- Initiation Date
- April 10, 2026
- Classification Date
- May 13, 2026
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327, United States
Description
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
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.
US Nationwide and the countries of Israel and Canada.
449 units