Z-2185-2026Class II
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions / initiated 2026-04-10 / Open, Classified / root cause: manufacturing process
Stryker Sustainability Solutions began a recall of CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER on . FDA classified it as Class II and gives the reason as "Incomplete seals on sterile product". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2185-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Stryker Sustainability Solutions
- Product
- CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Product code
- NLH Catheter, Recording, Electrode, Reprocessed
- Reason for recall
- Incomplete seals on sterile product
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Stryker issued a Medical Device Recall notice to its consignees on 4/10/2026 via USPS certified mail. The notice explained the product issue, potential risk, and requested the following: "Customer Actions Requested: Our records indicate that you may have distributed, received and/or used the above affected products. 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form and return the completed via email to [email protected], or use the QR Code on Attachment B. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility." "For any additional information or questions please reach out to [email protected] or Stryker Customer Service at 800-624-4422."
- Quantity in commerce
- 816 units
- Distribution
- US Nationwide and the countries of Israel and Canada.
- Product codes and lots
- 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, 4953204, 4977769, 5004217, 5034572, 5069609, 3444721, 4793099, 4825574, 4882691, 4937992, 4953205, 4977771, 5004219, 5034573, 5071436, 3446184, 4793102, 4825577, 4882693, 4937996, 4953206, 4977773, 5004221, 5034655, 5072106, 3476984, 4793119, 4825814, 4882694, 4938440, 4953338, 4980428, 5005557, 5034903, 5072107, 3485190, 4794754, 4826925, 4882695, 4938441, 4953339, 4980840, 5005558, 5037952, 5072206, 3485192, 4794914, 4826926, 4883802, 4938442, 4953340, 4980841, 5005932, 5037953, 5072407, 3610789, 4795026, 4826927, 4883812, 4940663, 4953341, 4980842, 5005933, 5038342, 5072408, 3662960, 4796837, 4826928, 4883949, 4940850, 4953342, 4980843, 5012759, 5038392, 5072409, 3689125, 4796969, 4826929, 4883950, 4940851, 4953343, 4980844, 5012977, 5038393, 5072410, 3689126, 4797346, 4826930, 4883951, 4941131, 4953344, 4980873, 5014498, 5038394, 5072411, 3697347, 4797347, 4827995, 4883952, 4941133, 4953345, 4980874, 5017458, 5040937, 5072412, 3697352, 4797348, 4827997, 4883953, 4941138, 4955023, 4980875, 5017459, 5040938, 5073110, 3703895, 4797349, 4828183, 4883954, 4941163, 4955024, 4980876, 5017460, 5040939, 5073111, 3703898, 4797351, 4829479, 4890927, 4941164, 4955025, 4980877, 5017461, 5043130, 5073112, 3703899, 4797353, 4830599, 4890957, 4941165, 4960181, 4980878, 5017530, 5043131, 5073113, 3715609, 4797354, 4830791, 4890959, 4941166, 4960193, 4980879, 5017531, 5043134, 5076106, 3715640, 4797356, 4830793, 4890972, 4941167, 4960201, 4980880, 5017532, 5043135, 5076108, 3729296, 4797358, 4830794, 4891905, 4941168, 4960210, 4983266, 5017535, 5043372, 5076109, 3729298, 4797359, 4830991, 4891906, 4941169, 4960224, 4983270, 5017537, 5043681, 5076111, 3976771, 4797363, 4831021, 4891907, 4941170, 4960226, 4983272, 5017538, 5043944, 5076112, 3979774, 4797364, 4833203, 4891908, 4941175, 4960620, 4983284, 5017542, 5044078, 5076115, 4020150, 4797365, 4837752, 4891909, 4941951, 4960725, 4984093, 5019519, 5044079, 5076118, 4022512, 4797876, 4837754, 4891910, 4941953, 4960726, 4984094, 5019520, 5044082, 5076120, 4050955, 4797889, 4837843, 4891911, 4941954, 4960727, 4984097, 5019522, 5044083, 5076121, 4086384, 4798288, 4838883, 4891912, 4941955, 4960728, 4984302, 5019566, 5044084, 5076126, 4086387, 4799276, 4840238, 4891913, 4947436, 4960729, 4985812, 5021631, 5044087, 5076127, 4481221, 4799821, 4841966, 4891914, 4947437, 4961610, 4985815, 5021781, 5044203, 5076128, 4614498, 4800185, 4842013, 4892202, 4947439, 4961611, 4985821, 5021782, 5044204, 5076129, 4614502, 4800186, 4844645, 4896329, 4947440, 4961612, 4985823, 5021819, 5044206, 5076130, 4649179, 4800188, 4845486, 4896330, 4947441, 4961613, 4985824, 5021820, 5044253, 5076131, 4650571, 4800193, 4845490, 4896331, 4947443, 4961614, 4986557, 5021821, 5044261, 5076134, 4663387, 4800194, 4845491, 4896332, 4950355, 4961615, 4987036, 5023691, 5044420, 5082198, 4668855, 4800195, 4847650, 4896333, 4950356, 4961616, 4987393, 5023946, 5044421, 5082202, 4673972, 4800198, 4849977, 4896334, 4950549, 4961617, 4987587, 5025606, 5045183, 5082205, 4726087, 4800199, 4850105, 4896419, 4950553, 4962190, 4990610, 5025607, 5045185, 5082207, 4726095, 4800200, 4850107, 4896421, 4953131, 4962191, 4990820, 5025608, 5045186, 5082209, 4726096, 4800204, 4853343, 4896422, 4953133, 4962981, 4990821, 5025724, 5045891, 5082211, 4726103, 4800206, 4854412, 4896423, 4953134, 4962982, 4990822, 5025725, 5052613, 5082212, 4726780, 4800279, 4855363, 4896424, 4953136, 4963015, 4992270, 5025727, 5052614, 5082213, 4728807, 4800874, 4855364, 4897428, 4953137, 4963016, 4993094, 5025728, 5052615, 5082214, 4728839, 4800876, 4855367, 4937750, 4953138, 4963017, 4993095, 5025729, 5053557, 5082215, 4729213, 4800877, 4855666, 4937754, 4953139, 4963040, 4993096, 5025895, 5053558, 5082216, 4730622, 4801737, 4856278, 4937757, 4953140, 4963308, 4993111, 5025912, 5053559, 5082217, 4730634, 4801959, 4859383, 4937759, 4953142, 4963309, 4993119, 5025919, 5053560, 5082218, 4731318, 4802512, 4859384, 4937760, 4953144, 4963310, 4993226, 5026193, 5053561, 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2174-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2175-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2176-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2177-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2178-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2179-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2180-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2181-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2182-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2183-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2184-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2185-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2186-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2187-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2188-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2189-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2190-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2191-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2192-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2193-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2194-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2195-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2196-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2197-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2198-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2199-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.