Daig Livewire Steerable Catheter Recall Issued
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Stryker Sustainability Solutions is recalling 107 units of the Daig Livewire Steerable reprocessed electrophysiology catheter due to incomplete seals on sterile product.
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.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Stryker Sustainability Solutions initiated a voluntary recall of the Daig Livewire Steerable reprocessed electrophysiology catheter because of incomplete seals on the sterile product.
Which Products Are Affected
The recall affects 107 units of Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER. The UDI is 00885825007270. Affected lot numbers include: 4026564, 4229299, 4801695, 4953879, 4987354, 5020148, 5075816, 4062382, 4229325, 4820358, 4953880, 4993906, 5034504, 5075889, 4126798, 4274291, 4821138, 4953881, 4993907, 5034505, 5075890, 4133063, 4294908, 4835292, 4953882, 4993909, 5044394, 5075900, 4159795, 4393599, 4841302, 4972396, 4993911, 5044402, 5075908, 4185728, 4487172, 4842791, 4972397, 4998472, 5047707, 4186431, 4550977, 4857135, 4972398, 4998473, 5053484, 4202027, 4574015, 4866297, 4972399, 4998474, 5058443, 4229211, 4584299, 4872587, 4972415, 5004432, 5063958, 4229292, 4594942, 4873162, 4987352, 5014723, 5066753, 4229294, 4737174, 4881443, 4987353, 5019469, 5066980. Distribution was nationwide in the United States and to Israel and Canada. The FDA recall number is Z-2192-2026.
What You Should Do
Consumers should follow instructions provided by Stryker Sustainability Solutions for returning affected products.
Why This Matters
The recall involves a Class II medical device distributed across the US, Israel, and Canada.
Source
FDA recall number Z-2192-2026 (report date 20260520).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,478 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.