FDA-Device2026-05-20Class IIPACKAGING DEFECT

Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals

OTHERNationwide distribution

Stryker Daig Livewire catheters recalled for incomplete sterile seals

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.
Hazard

Incomplete seals on sterile product

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-2197-2026

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