FDAFDA recall Z-0085-2027 · Oct 14, 2026
Stryker Sustainability Solutions: BARD EP XT DECAPOLAR STEERABLE recall
Recall found
Product
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
- Quantity
- 10
- Distribution
- US Nationwide distribution in the state of NJ.
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-18
Source: openFDA enforcement record Z-0085-2027 · search recall number Z-0085-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.