ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE… — Class II medical device recall Z-0944-2025
Ongoing recall by Sklar Instruments, reported 2025-01-22, distributed nationwide. Reports of various packaging issues that may result in a breach of the sterile barrier.
| Recall number | Z-0944-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sklar Instruments, West Chester, PA, United States |
| Recall initiated | 2024-12-03 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 475 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 50649111067233, 50649111067622, 50649111067967, 50649111068964, 50649111069343, 50649111069572, 50649111069886, 50649111133884, 50649111134058 |
| Lot numbers | SK-119 |
| Model numbers | 96-2603, 96-2605, 96-2607, 96-2613, 96-2615, 96-2616, 96-2617, 96-3001, 96-3002 |
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological
Reason for recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
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-0944-2025. 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.