FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
Nationwide distributionMedical devices
What this means
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200344) due to incomplete seals on the sterile packaging. The incomplete seals could allow contamination of the sterile device. Affected lot numbers are listed by Stryker, and the recall impacts 28 units distributed in the US, Canada, and Israel.
- Check if you have received or are holding any of the affected lot numbers listed in this recall.
- Do not use the affected catheters.
- Contact Stryker Sustainability Solutions or your supplier for instructions on return or replacement.
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
28 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2176-2026More Stryker recalls
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