# FDA recall Z-0944-2025

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

## 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

## 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-0944-2025
- **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-0944-2025

## Citation

> AI Analytics. FDA recall Z-0944-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0944-2025. Source: US FDA. Licensed CC0.

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