Stryker Recalls Daig Livewire Steerable Catheter

Source: FDA · United States, Israel, Canada

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Stryker Sustainability Solutions is recalling 458 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 3, 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.

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What Happened

Stryker Sustainability Solutions initiated a voluntary recall of the Daig Livewire Steerable reprocessed electrophysiology catheter because of incomplete seals on sterile product.

Which Products Are Affected

The recall affects 458 units of Daig Livewire Steerable, Product Number 401932 (REPROCESSED ELECTROPHYSIOLOGY CATHETER) distributed nationwide in the United States and to Israel and Canada. Affected lots are identified by UDI 00885825007355 and include the following lot numbers: 4248065, 4625922, 4792899, 4880229, 4947722, 4982083, 5004927, 5022043, 5031874, 5063926, and many additional lots listed in the recall notice. The recall number is Z-2197-2026, classified as Class II, with initiation date April 10, 2026.

What You Should Do

Consumers and healthcare facilities should immediately check inventory for the affected lots and follow the recalling firm's instructions for return or disposal. Contact Stryker Sustainability Solutions for return and refund information.

Why This Matters

The incomplete seals may compromise product sterility, posing a risk of infection or other adverse events for patients undergoing procedures with these catheters.

Source

FDA Enforcement Report, recall number Z-2197-2026, report date May 20, 2026.

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 458 units of the Daig Livewire Steerable reprocessed electrophysiology catheter due to incomplete seals on sterile product.
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.