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 reprocessed BARD Dynamic Tip Steerable electrophysiology catheters (Product Number 200131) due to incomplete seals on the sterile packaging. The incomplete seals may compromise sterility, potentially allowing contamination of the device. Affected lot numbers span from 3966097 to 4762686, with 61 units distributed across the United States, Canada, and Israel.
- Check if you have received or are currently using this catheter and verify the product number 200131 and lot number against the affected list.
- Do not use affected catheters if you have them in stock.
- Contact Stryker Sustainability Solutions for instructions on device return or disposal.
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
61 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2175-2026More Stryker recalls
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