Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
Stryker Sustainability Solutions is recalling 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product. The catheters were distributed nationwide and in Israel and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The hazard is incomplete seals on a sterile medical device, which represents a potential sterility compromise rather than a confirmed contamination or reported adverse event. No illnesses or injuries are reported in the source text.
Plain-English summary
Stryker Sustainability Solutions is recalling the Daig Livewire Steerable electrophysiology catheter (Product Number 401915) because some units have incomplete seals on the sterile product. A total of 206 units are affected.
The recalled catheters were distributed in the United States, Israel, and Canada. The affected lot numbers are: 1772607, 3994138, 4539200, 4808444, 4985924, 5010522, 5042942, 2482952, 4046485, 4539206, 4808677, 4986242, 5010524, 5042944, 2521570, 4164020, 4540476, 4812775, 4986243, 5017909, 5042945, 2521636, 4166570, 4544644, 4817888, 4986244, 5018848, 5043881, 2521660, 4182322, 4549452, 4824089, 4986245, 5020135, 5043883, 2577590, 4183176, 4549458, 4824092, 4986256, 5020136, 5052391, 2711877, 4206584, 4549460, 4824093, 4986399, 5020139, 5056580, 2769403, 4216286, 4551863, 4825561, 4993904, 5020147, 5060152, 2769695, 4247577, 4567736, 4830114, 4993905, 5020149, 5060153, 2787951, 4260013, 4569285, 4833151, 4993910, 5020453, 5060154, 2919616, 4274184, 4569297, 4850593, 4993912, 5024412, 5060155, 2919619, 4275872, 4569532, 4854631, 4993914, 5024413, 5060156, 2919623, 4287229, 4569539, 4854632, 4993915, 5025667, 5060157, 2986771, 4295030, 4577350, 4861162, 4993916, 5029412, 5060158, 3186438, 4390731, 4579539, 4861163, 4993920, 5032327, 5060159, 3269091, 4414236, 4665004, 4861164, 4997912, 5032328, 5060160, 3364168, 4414244, 4671456, 4868220, 4999701, 5032329, 5080121, 3371014, 4461334, 4675658, 4890809, 4999901, 5032330, 5080812, 3371015, 4477262, 4677973, 4950295, 5001378, 5032331, 5081406, 3371464, 4487544, 4734148, 4972469, 5001380, 5033613, 5081407, 3372123, 4487545, 4735713, 4974049, 5003013, 5035986, 5085275, 3398046, 4495634, 4739300, 4974050, 5003014, 5038644, 5085394, 3411209, 4508984, 4748755, 4976259, 5003015, 5038647, 5085395, 3413279, 4539190, 4756237, 4976293, 5003016, 5041264, 5085396, 3469626, 4539191, 4771668, 4985775, 5003017, 5042936, 5085889, 3499568, 4539192, 4792718, 4985776, 5003018, 5042937, 3784873, 4539196, 4804384, 4985921, 5003019, 5042940, 3896863, 4539199, 4808394, 4985922, 5008867, 5042941. The product UDI is 00885825007300.
Healthcare providers should check for affected lot numbers and handle the catheters appropriately. Incomplete seals on sterile products may compromise sterility and safety.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 206
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI 00885825007300
- Lot Numbers: 1772607
- 3994138
- 4539200
- 4808444
- 4985924
- 5010522
- 5042942
- 2482952
- 4046485
- 4539206
- 4808677
- 4986242
- 5010524
- 5042944
- 2521570
- 4164020
- 4540476
- 4812775
- 4986243
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 26 products in this recall →Related recalls
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