Stryker Sustainability Solutions: Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Recall number

Z-2191-2026

Recalling firm

Stryker Sustainability Solutions

Product

Daig Livewire Steerable, Product Number 401904; 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

1352 units

Distribution

US Nationwide and the countries of Israel and Canada.

Lot, serial or model codes

UDI 00885825007263, Lot Numbers: 3016810, 4488621, 4592565, 4801485, 4882673, 4967856, 4993019, 5004980, 5043929, 5071232, 3481897, 4488631, 4592566, 4802770, 4882750, 4967857, 4993023, 5005187, 5043930, 5071390, 3625879, 4488632, 4592567, 4804079, 4882752, 4967858, 4993039, 5005189, 5043931, 5071391, 3839101, 4488634, 4592569, 4807663, 4882753, 4968857, 4993040, 5005332, 5043932, 5071455, 3957393, 4488637, 4592570, 4807753, 4882754, 4968859, 4993322, 5005666, 5043985, 5071456, 3969685, 4488639, 4592571, 4807830, 4882758, 4968860, 4993327, 5005943, 5043986, 5071458, 3969688, 4488714, 4593641, 4808039, 4883012, 4968861, 4993563, 5005944, 5043988, 5071963, 3969689, 4488715, 4593648, 4808040, 4883125, 4968862, 4993564, 5008502, 5043990, 5071964, 3969691, 4488739, 4593688, 4808043, 4883516, 4968863, 4993567, 5009554, 5044183, 5071999, 3997894, 4488740, 4593691, 4808044, 4883867, 4969223, 4993568, 5009555, 5044426, 5072263, 4033681, 4488741, 4600193, 4808744, 4883868, 4971027, 4993570, 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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

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

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