Sklar Instruments: Medical Device Recall in 2025 - (Recall #: Z-0947-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy

Product Classification:

Class II

Date Initiated: December 3, 2024

Date Posted: January 22, 2025

Recall Number: Z-0947-2025

Event ID: 95946

Reason for Recall:

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

Status: Ongoing

Product Quantity: 0 units

Code Information:

1) 96-4134M, UDI/DI 50649111492547, Lot codes: SK-114; 2) 96-4137M, UDI/DI 50649111492530, Lot codes: SK-116.

Distribution Pattern:

Domestic: Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated