FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
OTHERNationwide distribution
Stryker BARD Dynamic Tip Steerable recalled for incomplete sterile seals
Stryker Sustainability Solutions is recalling the BARD Dynamic Tip Steerable catheter (Product Number 6DYNTP001) because some units have incomplete seals on their sterile packaging. This affects 427 units distributed in the US, Canada, and Israel. No injuries have been reported.
- Check if you have a device matching Product Number 6DYNTP001 and one of the affected lot numbers listed in the recall notice.
- Do not use affected units; contact your healthcare provider or Stryker for instructions.
- Return the device to the supplier or manufacturer as directed.
Hazard
Incomplete seals on sterile product
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
427 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2177-2026More Stryker Sustainability Solutions recalls
- 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
- FDA-Device2026-05-20Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
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