PlainRecalls
FDA Devices Moderate Class II Ongoing

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe

Reported: January 22, 2025 Initiated: December 3, 2024 #Z-0953-2025

Product Description

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe

Reason for Recall

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

Details

Recalling Firm
Sklar Instruments
Units Affected
2500 units
Distribution
Domestic: Nationwide Distribution
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe. Recalled by Sklar Instruments. Units affected: 2500 units.
Why was this product recalled?
Reports of various packaging issues that may result in a breach of the sterile barrier.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0953-2025.