- Recalling firm
- SurgiSmoke Solutions
- Reason for recall
- Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
- Affected products (lot / model / serial)
- UDI-DI: 0860012888818; Lot 8264601
- Units affected
- 2505 units total
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.
- Firm location
- Saint Paul, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1925-2026
- Recall initiated
- March 16, 2026
- FDA classification date
- April 22, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98574
- Last updated on HTM Vibe
- July 24, 2026