MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2025 - (Recall #: Z-0754-2025)

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:

STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695

Product Classification:

Class II

Date Initiated: November 12, 2024

Date Posted: January 1, 2025

Recall Number: Z-0754-2025

Event ID: 95843

Reason for Recall:

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

Status: Ongoing

Product Quantity: 21,440 total

Code Information:

UDI: 00653160024869 (ea) 60653160024861 (case); Lot 2023011990

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated