FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions issued a recall of Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401932) due to incomplete seals on the sterile packaging. The incomplete seals could potentially allow contamination of the sterile product. A total of 458 units across multiple lot numbers were affected and distributed in the US, Canada, and Israel.
- Check your facility's inventory for any catheters matching Product Number 401932 and the affected lot numbers listed in this recall.
- Do not use any affected units.
- Contact your Stryker representative or the FDA for instructions on return or destruction of affected products.
- Review patient records if any affected catheters were used and consult with your medical team about appropriate follow-up if needed.
The agency's original wording
Hazard
Incomplete seals on sterile product
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
458 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2197-2026More Stryker recalls
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar with OptiView recalled for reusable port cracking risk
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar recalled for potential cracking or separation during use
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for potential cracking or separation during surgery
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for crack or separation risk during use
- FDA-Device2026-09-23Ethicon Endo-Surgery XCEL Bladeless Trocar recalled for cracking or separation during use
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.