MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2196-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: July 26, 2023

Recall Number: Z-2196-2023

Event ID: 92466

Reason for Recall:

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Status: Ongoing

Product Quantity: 2420 units

Code Information:

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ44410G. UDI/DI (EA)10193489958447, UDI/DI (CS)40193489958448; b) Model Number DYNJ9048708I. UDI/DI (EA)10195327072735, UDI/DI (CS)40195327072736; c) Model Number PHS762887001B. UDI/DI (EA)10889942849314, UDI/DI (CS) 40889942849315; d) Model Number TVS4700. UDI/DI (EA)10816982023398, UDI/DI (CS)40816982023399;

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated