Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2…

Recall date

December 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0946-2025

FDA classification

Class II

Brand / firm

Sklar Instruments

Sold / distributed

Domestic: Nationwide Distribution

Why it was recalled

Reports of various packaging issues that may result in a breach of the sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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