FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic Deca Steerable catheter recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions has recalled BARD Dynamic Deca Steerable electrophysiology catheters (Product Number 201101) due to incomplete seals on the sterile packaging. The affected catheters may not maintain sterility, which could pose a risk to patients. Approximately 3,063 units in multiple lot numbers are included in this recall.
- Check if you have any affected BARD Dynamic Deca Steerable catheters (Product Number 201101) in the listed lot numbers.
- Do not use affected units if sterility cannot be verified.
- Contact Stryker Sustainability Solutions or your medical device supplier for instructions on replacement or return.
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
3063 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2174-2026More Stryker recalls
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