- Recalling firm
- Stryker Sustainability Solutions
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
- Units affected
- 10
- Distribution pattern
- US Nationwide distribution in the state of NJ.
- Firm location
- Tempe, AZ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0085-2027
- Recall initiated
- August 18, 2026
- FDA classification date
- October 5, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99655
- Last updated on HTM Vibe
- October 21, 2026
