MAJOR THORACOSCOPY BASIN — Class II medical device recall Z-2258-2025
Ongoing recall by AVID Medical, Inc., reported 2025-08-13, distributed in CA, IL, MD, OH, PA, TX, WA. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
| Recall number | Z-2258-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2025-06-11 |
| Classified | 2025-08-04 |
| Reported by FDA | 2025-08-13 |
| Distributed | CA, IL, MD, OH, PA, TX, WA |
| Quantity | 128 units |
| UPC / GTIN / UDI-DI | 10809160381311, 10809160403730, 10809160440940 |
| Lot numbers | 1580032, 1590461, 1590463, 1604743, 1613180, 1613182, 1618989, 1641040 |
| Model numbers | NIHB0022-09, NIHB0022-11, NIHB0022-12 |
Product
MAJOR THORACOSCOPY BASIN. Medical convenience kit.
Reason for recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2258-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.