Daig Livewire Steerable Catheter Recall Issued by Stryker
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Stryker Sustainability Solutions has initiated a Class II recall of 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile products.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 2026 and geographically references United States, Israel, Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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What Happened
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters because of incomplete seals on sterile product.
Which Products Are Affected
The recall affects 206 units of Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER. UDI is 00885825007300. Affected lot numbers include: 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. Distributed nationwide in the US and to Israel and Canada. Recall number Z-2195-2026.
What You Should Do
Consumers should contact Stryker Sustainability Solutions regarding the recalled products.
Why This Matters
This Class II recall involves a device that may cause temporary or reversible adverse health consequences due to potential compromised sterility.
Source
FDA Recall Z-2195-2026 - Stryker Sustainability Solutions, Tempe, AZ
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,586 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.