Stryker Sustainability Solutions recalls BARD EP XT DECAPOLAR STEERABLE
- Recalling company
- Stryker Sustainability Solutions
- Product
- BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 18, 2026
- Reported
- Oct 14, 2026
- Distribution
- US Nationwide distribution in the state of NJ.
- Status
- Ongoing
- Quantity
- 10
- Lot / codes
- UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
- Company location
- Tempe, AZ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0085-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0085-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.