# FDA recall Z-0946-2025

> **Sklar Instruments** · Class II · device recall initiated 2024-12-03.

## 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

## Reason for recall

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

## Distribution

Domestic: Nationwide Distribution

## Key facts

- **Recall number:** Z-0946-2025
- **Recalling firm:** Sklar Instruments
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-03
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2025

## Citation

> AI Analytics. FDA recall Z-0946-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0946-2025. Source: US FDA. Licensed CC0.

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