--- title: "CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYS... — FDA record Z-2185-2026 | Is It on Recall" description: "Incomplete seals on sterile product" url: https://isitonrecall.com/recall/fda-device-z-2185-2026-cs-uni-directional-w-auto-id-product-number-d135304-reprocessed-electrophysiology-catheter/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER — FDA record Z-2185-2026 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 Apr 10, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER - **Reason**: Incomplete seals on sterile product - **Classification**: Class II - **Recalling firm**: Stryker Sustainability Solutions - **Quantity**: 816 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2185-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2185-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI 07613327357318, Lot Numbers: 3351120, 4756053, 4820613, 4880639, 4937971, 4953195, 4974710, 5002528, 5033775, 5067727, 3351123, 4761288, 4821747, 4880648, 4937973, 4953196, 4975470, 5002529, 5033776, 5069585, 3352961, 4764911, 4821750, 4880654, 4937974, 4953197, 4975472, 5002530, 5034566, 5069588, 3369921, 4766954, 4822911, 4880655, 4937975, 4953198, 4975598, 5002531, 5034567, 5069594, 3369925, 4766956, 4824997, 4880656, 4937976, 4953200, 4977751, 5002855, 5034568, 5069597, 3369927, 4767155, 4825261, 4880657, 4937977, 4953201, 4977753, 5003960, 5034569, 5069599, 3369928, 4772390, 4825262, 4880658, 4937982, 4953202, 4977754, 5004190, 5034570, 5069603, 3425440, 4775105, 4825572, 4880938, 4937983, 4953203, 4977768, 5004192, 5034571, 5069606, 3443600, 4786470, 4825573, 4882690, 4937988, 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5083460, 4731328, 4802614, 4859413, 4937763, 4953145, 4966247, 4993227, 5026194, 5054082, 5085972, 4732001, 4802815, 4859417, 4937769, 4953146, 4966248, 4993228, 5026692, 5056201, 5085973, 4733531, 4802925, 4859709, 4937836, 4953147, 4968799, 4994012, 5026693, 5056202, 5086369, 4734479, 4803529, 4860609, 4937837, 4953148, 4972869, 4994080, 5026832, 5056203, 5086371, 4735289, 4803533, 4861443, 4937838, 4953169, 4972872, 4994803, 5029136, 5056848, 5086372, 4736363, 4803808, 4864439, 4937839, 4953171, 4973398, 4994860, 5029137, 5057349, 5086373, 4737394, 4804041, 4864848, 4937840, 4953173, 4973417, 4994863, 5032245, 5058020, 5086374, 4738377, 4806961, 4864851, 4937841, 4953176, 4973418, 4994866, 5032246, 5058021, 5086376, 4738390, 4807448, 4864875, 4937847, 4953177, 4973421, 4998169, 5033410, 5059047, 5086377, 4738391, 4807605, 4864876, 4937848, 4953178, 4973426, 4998170, 5033412, 5059077, 5086379, 4738395, 4807717, 4864877, 4937851, 4953179, 4973427, 4998947, 5033591, 5059078, 5086380, 4739012, 4807718, 4867552, 4937854, 4953180, 4973430, 4998948, 5033619, 5061477, 5086521, 4741793, 4814727, 4867805, 4937855, 4953185, 4973463, 4998950, 5033620, 5061478, 5086522, 4741794, 4818092, 4868856, 4937856, 4953186, 4973465, 4998951, 5033621, 5061479, 5086523, 4749251, 4818093, 4869232, 4937857, 4953188, 4973466, 4998952, 5033622, 5061480, 5086525, 4749265, 4818095, 4870634, 4937858, 4953190, 4973468, 4998953, 5033623, 5061481, 5086526, 4749373, 4818194, 4876110, 4937859, 4953191, 4973470, 4999004, 5033624, 5062616, 5086539, 4749406, 4820176, 4877011, 4937863, 4953192, 4973476, 4999893, 5033625, 5062617, 5086666, 4749796, 4820610, 4880527, 4937865, 4953193, 4973858, 5002388, 5033773, 5062618, 5086667, 4755379, 4820611, 4880638, 4937868, 4953194, 4974111, 5002527, 5033774, 5066983. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide and the countries of Israel and Canada. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: May 20, 2026 - **Recall initiation date**: Apr 10, 2026 - **Center classification date**: May 13, 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 to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2185-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Stryker Sustainability Solutions records](https://isitonrecall.com/brand/stryker-sustainability-solutions/)