MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2294-2023)

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:

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A

Product Classification:

Class II

Date Initiated: May 15, 2023

Date Posted: August 9, 2023

Recall Number: Z-2294-2023

Event ID: 92399

Reason for Recall:

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Status: Ongoing

Product Quantity: 192 kits

Code Information:

Model Number: DYNJ45158A, UPC Number: 088827750721, all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated