Stop using nowMedical device recall · FDA · Published August 18, 2026
Bard EP XT Decapolar Catheter Recall: Risk of Infection from Breached Sterile Barrier
Stryker recalls Bard EP XT Decapolar Steerable Catheters with potential breached sterile barrier. This may cause infection, blood clots, or tissue damage. Stop using immediately if you have the specific lot.
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.
“Bard EP XT Decapolar Catheter Recall: Risk of Infection from Breached Sterile Barrier.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629589-stryker-sustainability-solutions-recalls-bard-ep-xt-decapolar-steerable-diagnostic. Based on FDA recall #Z-0085-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2027%22&limit=1).
The FDA announced on August 18, 2026, that Stryker Sustainability Solutions is recalling the BARD EP XT Decapolar Steerable Diagnostic EP Catheter due to a potential breach in the sterile barrier. The agency issued recall number Z-0085-2027 for the Class II device.
How to tell if you have it
Brand: Stryker
Product: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM
REF: 201007
UDI-DI: 00885825003838
Lot: 5640704
Serial: 5097742
Distribution Date: May 26th 2026
Quantity: 10 units
Sold: US Nationwide, specifically in New Jersey
The hazard
According to the FDA, the diagnostic electrophysiology catheter may have a breached sterile barrier on the straight seal side of the primary pouch. If used, this defect could lead to particulate embolization, infection, thrombus, or granuloma formation from particulate matter.
Context
GovInfoNow's records show Stryker Sustainability Solutions has issued 22 other recalls since December 1, 2017. Recent brand recalls include the Stryker XCEL Bladeless Trocar on August 19, 2026, due to cracking risk, and the Stryker Daig Livewire Steerable Catheter on April 10, 2026, for incomplete sterile seals. Other recent recalls of similar products include Bard Peripheral Vascular's Broviac Cutdown Trays (December 12, 2025), Medtronic DLP Retrograde Cannula (April 21, 2026), and Bard Safe-T-Centesis Catheter Drainage Tray (November 6, 2025).
How to tell if you have this one
Check for the lot number 5640704 and serial number 5097742 on the catheter packaging. These units were distributed in New Jersey starting May 26, 2026.
Brand
Stryker
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop using it now
Immediately discard the catheter if you have the lot number 5640704 or serial number 5097742.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0085-2027 (August 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0085-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.