# FDA recall Z-0954-2025

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

## Product

ECONO STERILE medical procedure kits labeled as:    1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A;    2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353;    3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A;    4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A;    5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A;    6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417;    7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580;    8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581;    9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A;    10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583;    11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A;    12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585;    13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Mod

## 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-0954-2025
- **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-0954-2025

## Citation

> AI Analytics. FDA recall Z-0954-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0954-2025. Source: US FDA. Licensed CC0.

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