MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-3069-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

CRANIOTOMY PACK, Pack Number DYNJ46552O

Product Classification:

Class II

Date Initiated: June 18, 2024

Date Posted: September 18, 2024

Recall Number: Z-3069-2024

Event ID: 95127

Reason for Recall:

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

Status: Ongoing

Product Quantity: 188 units

Code Information:

UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872

Distribution Pattern:

US: TX, IL, CA

Voluntary or Mandated:

Voluntary: Firm initiated