FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
What this means
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.
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
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 recalls
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