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-2197-2026More Stryker Sustainability Solutions recalls
- FDA-Device2026-05-20Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD Dynamic Deca Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD EP XT Decapolar Steerable catheters recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief