MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2157-2023)

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: PEDIATRIC EP PACK, Model Number DYNJ45158A

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: July 26, 2023

Recall Number: Z-2157-2023

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: 36 units

Code Information:

all lots within expiry, distributed from Medline between December 2017 - May 2023: UDI/DI (EA) 10888277507210, UDI/DI (CS) 40888277507211

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