Sklar Instruments: Medical Device Recall in 2025 - (Recall #: Z-0928-2025)

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: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)

Product Classification:

Class II

Date Initiated: December 3, 2024

Date Posted: January 22, 2025

Recall Number: Z-0928-2025

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:

96-2478, UDI/DI 50649111492615, Lot codes: SK-121

Distribution Pattern:

Domestic: Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated