MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2318-2023)

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 the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;

Product Classification:

Class II

Date Initiated: May 15, 2023

Date Posted: August 9, 2023

Recall Number: Z-2318-2023

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: 1,182 kits

Code Information:

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ69864A, UPC Number: 019532713205. b. Model Number: DYNJ82257, UPC Number: 019532718165. c. Model Number: DYNJ60224C, UPC Number: 019532715184.

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