Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA device recall Z-2187-2026 · posted 2026-05-13 · Open, Classified

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

Incomplete seals on sterile product

Action taken

Stryker issued a Medical Device Recall notice to its consignees on 4/10/2026 via USPS certified mail. The notice explained the product issue, potential risk, and requested the following: "Customer Actions Requested: Our records indicate that you may have distributed, received and/or used the above affected products. 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form and return the completed via email to SSSPFA@stryker.com, or use the QR Code on Attachment B. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility." "For any additional information or questions please reach out to SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422."

Root cause

Process control

Status

Open, Classified

Product code

NLH

Quantity affected

108 units

Distribution

US Nationwide and the countries of Israel and Canada.

Date initiated

2026-04-10

Date posted

2026-05-13

Location

Tempe, AZ

Related 510(k) clearances