Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Stryker Sustainability Solutions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
BARD EP XT DECAPOLAR STEERABLEDIAGNOSTIC EP CATHETER6FLARGE 4.0102-5-2MM
- REF201007
- Lot codes and dates
- UDI-DI00885825003838
- Lot5640704
- Serial5097742
- Distribution DateMay 26th 2026
- Amount recalled
- 10
Where it was sold
- Nationwide
- NJ
Why it was recalled
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
This product could cause temporary or reversible health problems — stop using it.
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