FDA Medical devices recall ·
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR… recall
- Recall number
- Z-0946-2025
- 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
- 75 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 HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators
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) 96-0960, UDI/DI 50649111474796, Lot codes: FSS5; 2) 96-0961, UDI/DI 50649111474802, Lot codes: FSS5; 3) 96-0962, UDI/DI 50649111474819, Lot codes: FSS5; 4) 96-0963, UDI/DI 50649111474826, Lot codes: FSS5; 5) 96-0964, UDI/DI 50649111474833, Lot codes: FSS5; 6) 96-0965, UDI/DI 50649111474840, Lot codes: FSS5; 7) 96-0966, UDI/DI 50649111474857, 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-0946-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.