# FDA recall Z-0939-2025

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

## Product

ECONO STERILE medical procedure kits labeled as:    1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;   2) ECONO STERILE DRESSING FCP 5.5"  CS/25LG,Model Number 94-0290;   3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291;   4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691;   5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414;   6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924;   7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034;   8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146;   9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616;   10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A;   11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289;   12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293;   13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A;   14) ECONO STERI

## 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-0939-2025
- **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-0939-2025

## Citation

> AI Analytics. FDA recall Z-0939-2025. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0939-2025. Source: US FDA. Licensed CC0.

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