FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Recall number
- Z-2188-2026
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Status
- Open, Classified
- Initiated
- 2026-04-10
- Posted
- 2026-05-13
- Terminated
- not on file
- Reason
- Incomplete seals on sterile product
- Root cause
- Process control
- Action
- 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."
- Quantity
- 19 units
- Distribution
- US Nationwide and the countries of Israel and Canada.
- Lot, serial or model codes
- UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.
- 510(k) numbers
- ["K012708","K030187","K052603","K100254"]
- PMA numbers
- not on file
- Product code
- NLH
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28