Recall archive / FDA device enforcement
GYN LAPAROSCOPY PACK. Medical convenience kit. — FDA record Z-2250-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- GYN LAPAROSCOPY PACK. Medical convenience kit.
- Reason
- CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Classification
- Class II
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 346 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2250-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. NAFB055-08, NAMC436-11, VMCC030-06; UDI: 10809160405185, 10809160417621, 10809160415245, 10809160419021; Kit Lot No. 1595523, 1598524, 1598523, 1628236, 1634348, 1636865, 1645025, 1645227, 1608234, 1608349, 1608466, 1613607, 1613139, 1613608, 1616927, 1622475, 1628656, 1632993, 1596145, 1603597, 1608059, 1619856. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: CA, IL, MD, OH, PA, TX, WA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 13, 2025
- Recall initiation date
- Jun 11, 2025
- Center classification date
- Aug 4, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.