- Recalling firm
- Cook Incorporated
- Reason for recall
- The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
- Affected products (lot / model / serial)
- UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
- Units affected
- 97 units
- Distribution pattern
- US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
- Firm location
- Bloomington, IN, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0163-2027
- Recall initiated
- September 16, 2026
- FDA classification date
- October 15, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99875
- Last updated on HTM Vibe
- October 27, 2026
