Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M…

Recall date

December 3, 2024

Source

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

Recall number

Z-0947-2025

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 MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy