Stryker Recalls Daig Livewire Steerable Electrophysiology Catheters

Source: FDA · United States, Israel, Canada

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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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Stryker Sustainability Solutions is recalling 1,352 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States, Israel, Canada. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.