Stryker Recalls Daig Livewire Steerable Electrophysiology Catheters
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Stryker Sustainability Solutions is recalling 1,352 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging.
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 Daig Livewire Steerable reprocessed electrophysiology catheters because of incomplete seals on sterile product.
Which Products Are Affected
The recall covers Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER. A total of 1,352 units are affected. The UDI is 00885825007263. Affected lot numbers include: 3016810, 4488621, 4592565, 4801485, 4882673, 4967856, 4993019, 5004980, 5043929, 5071232 and numerous additional lots listed in the recall notice. Distribution was to US Nationwide and the countries of Israel and Canada.
What You Should Do
Consumers should follow instructions provided by the recalling firm regarding the affected devices.
Why This Matters
The Class II recall involves a sterility concern with reprocessed medical devices distributed across the United States, Israel, and Canada.
Source
FDA recall number Z-2191-2026. Event ID 98708. 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 (1,010 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.