Sklar Instruments: Medical Device Recall in 2025 - (Recall #: Z-0944-2025)

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 GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological

Product Classification:

Class II

Date Initiated: December 3, 2024

Date Posted: January 22, 2025

Recall Number: Z-0944-2025

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: 475 units

Code Information:

1) 96-2603, UDI/DI 50649111067233, Lot Codes: SK-119; 2) 96-2605, UDI/DI 50649111067622, Lot Codes: SK-119; 3) 96-2607, UDI/DI 50649111067967, Lot Codes: SK-119; 4) 96-2613, UDI/DI 50649111068964, Lot Codes: SK-119; 5) 96-2615, UDI/DI 50649111069343, Lot Codes: SK-119; 6) 96-2616, UDI/DI 50649111069572, Lot Codes: SK-119; 7) 96-2617, UDI/DI 50649111069886, Lot Codes: SK-119; 8) 96-3001, UDI/DI 50649111133884, Lot Codes: SK-119; 9) 96-3002, UDI/DI 50649111134058, Lot Codes: SK-119.

Distribution Pattern:

Domestic: Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated