Agency classClass IIOur severity:High FDA (Devices)·Z-2188-2026·Announced 2026-05-20

Reprocessed Electrophysiology Catheter Daig Livewire Steerable recalled

Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product. The recall affects 19 units distributed nationwide in the US, Israel, and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with a sterile barrier compromise (incomplete seal). Although no reported illnesses or injuries are mentioned in the source, sterile product integrity issues create a risk of contamination and infection, which qualifies as a high-risk-of-harm medical device defect.

Plain-English summary

Stryker Sustainability Solutions is recalling the Daig Livewire Steerable, Product Number 401582 reprocessed electrophysiology catheter. The reason for the recall is incomplete seals on the sterile product.

A total of 19 units were affected by this recall. The product was distributed in the United States, Israel, and Canada.

The affected lot numbers are: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, and 4985861. The product UDI is 00885825006884.

If you have this product, contact your healthcare facility or Stryker Sustainability Solutions for instructions on handling and return.

The recalled product

Product: Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Manufacturer: Stryker Sustainability Solutions
Category: Medical Device — Electrophysiology Catheter
Hazard: sterile-seal-failure
infection-risk
Affected units: 19

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI 00885825006884
Lot Numbers: 3002664
4092049
4580888
4627994
4778840
4860529
4998452
4026540
4098358
4620256
4627999
4813542
4985859
4072508
4498128
4620257
4755333
4860528
4985861.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 26 products in this recall →

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Same hazard · sterile seal failure