Stryker Recalls Daig Livewire Steerable Catheters

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Stryker Sustainability Solutions is recalling 108 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 3, 2026 and geographically references United States. 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, medical-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

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER. UDI 00885825006877. 108 units. Affected lot numbers: 3683857, 3836878, 3981321, 4042778, 4053585, 4103495, 4496897, 3683858, 3891551, 3991434, 4052721, 4053586, 4111212, 4496898, 3694871, 3932470, 3991439, 4052723, 4103479, 4111213, 4549309, 3762375, 3942462, 3991442, 4052726, 4103480, 4111214, 4549312, 3764605, 3964790, 3991444, 4052727, 4103481, 4111216, 4570926, 3764606, 3971860, 3991445, 4052735, 4103482, 4111218, 4570936, 3767575, 3973797, 4042769, 4052747, 4103483, 4111219, 4749790, 3767954, 3981001, 4042773, 4053579, 4103491, 4496884, 4753244, 3769052, 3981005, 4042776, 4053580, 4103492, 4496886, 4954168, 3808357, 3981320, 4042777, 4053582, 4103493, 4496892. Distributed US Nationwide and to Israel and Canada. Recall number Z-2187-2026. Classification: Class II. Recall initiation date: 20260410.

What You Should Do

No specific consumer instructions are provided in the recall notice.

Why This Matters

The ongoing Class II recall affects 108 units of reprocessed medical devices distributed across the United States, Israel, and Canada.

Source

FDA Enforcement Report, recall number Z-2187-2026.

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Stryker Sustainability Solutions is recalling 108 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile products.
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. 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.