ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE… — Class II medical device recall Z-0938-2025
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-0938-2025 |
|---|---|
| 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 | 150 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 50649111481657, 50649111481664, 50649111481671, 50649111493612, 50649111493629, 50649111493636, 50649111493643, 50649111493650, 50649111493667, 50649111493674, 50649111493681, 50649111493964 |
| Lot numbers | FSS4, FSS5, FSS6 |
| Model numbers | 96-4176, 96-4177, 96-5434, 96-5435, 96-5436, 96-5437, 96-5438, 96-5439, 96-5440, 96-5492, 96-5493, 96-5494 |
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices
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-0938-2025. 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.