FDA Medical devices recall ·
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES… recall
- Recall number
- Z-0944-2025
- Date
- (initiated December 3, 2024)
- Company / brand
- Sklar Instruments
1333 Lenape Rd, West Chester, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 475 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Reports of various packaging issues that may result in a breach of the sterile barrier.
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
1) 96-2603, UDI/DI 50649111067233, Lot Codes: SK-119; 2) 96-2605, UDI/DI 50649111067622, Lot Codes: SK-119; 3) 96-2607, UDI/DI 50649111067967, Lot Codes: SK-119; 4) 96-2613, UDI/DI 50649111068964, Lot Codes: SK-119; 5) 96-2615, UDI/DI 50649111069343, Lot Codes: SK-119; 6) 96-2616, UDI/DI 50649111069572, Lot Codes: SK-119; 7) 96-2617, UDI/DI 50649111069886, Lot Codes: SK-119; 8) 96-3001, UDI/DI 50649111133884, Lot Codes: SK-119; 9) 96-3002, UDI/DI 50649111134058, Lot Codes: SK-119.
Distribution
Domestic: Nationwide Distribution
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-0944-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.