Home / Recalls / Stryker Sustainability Solutions / Z-0085-2027

Z-0085-2027 Class II Ongoing

Recalled by Stryker Sustainability Solutions — Tempe, AZ

FDA device recall Z-0085-2027 was initiated by Stryker Sustainability Solutions on Aug 18, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 10.

Recall Details

Product Type: Devices
Report Date: Oct 14, 2026
Initiation Date: Aug 18, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10

Product Description

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.

Distribution Pattern

US Nationwide distribution in the state of NJ.

Code Information

UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0085-2027
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.