- Recalling firm
- Cook Incorporated
- Reason for recall
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Affected products (lot / model / serial)
- Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755; Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335.
- Units affected
- 20 units
- Distribution pattern
- Worldwide distribution.
- Firm location
- Bloomington, IN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1786-2026
- Recall initiated
- March 5, 2026
- FDA classification date
- April 6, 2026
- FDA report date
- April 15, 2026
- FDA event ID
- 98495
- Last updated on HTM Vibe
- July 24, 2026