FDA Medical devices recall ·
GEN LAPAROSCOPY PACK. Medical convenience kit recall
- Recall number
- Z-2246-2025
- Date
- (initiated June 11, 2025)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 321 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GEN LAPAROSCOPY PACK. Medical convenience kit.
Why was it recalled?
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. VMCC007-12; UDI: 10809160357200; Kit Lot No. 1592617, 1598707, 1608042, 1608043, 1621654.
Distribution
Domestic: CA, IL, MD, OH, PA, TX, WA.
States: California Illinois Maryland Ohio Pennsylvania Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2246-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.