- Recalling firm
- Oscor Inc.
- Reason for recall
- Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Affected products (lot / model / serial)
- All Lots within Expiry/GTIN:00885672009793, 00813502010664
- Units affected
- 355 units
- Distribution pattern
- Distribution in the US state of MA
- Firm location
- Palm Harbor, FL, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2678-2026
- Recall initiated
- June 10, 2026
- FDA classification date
- July 10, 2026
- FDA report date
- July 22, 2026
- FDA event ID
- 99102
- Last updated on HTM Vibe
- July 28, 2026