Sklar Instruments: Medical Device Recall in 2025 - (Recall #: Z-0935-2025)

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 VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous procedures

Product Classification:

Class II

Date Initiated: December 3, 2024

Date Posted: January 22, 2025

Recall Number: Z-0935-2025

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: 1050 units

Code Information:

1) 96-4020M, UDI/DI 50649111476356, Lot codes: SK-125; 2) 96-4021M, UDI/DI 50649111476363, Lot codes: SK-125, SK-128; 3) 96-4022M, UDI/DI 50649111476370, Lot codes: SK-125.

Distribution Pattern:

Domestic: Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated