MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2339-2023)

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. BREAST BIOPSY KIT, Model Number: DYNDA1224A, DYNDA1224B; b. BREAST BIOPSY TRAY, Model Number: SPEC0130C; c. BREAST IMAGING TRAY, Model Number: MNS11895; d. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496; e. ULTRASOUND GUIDE BREAST BIOPSY, Model Number: DYNDH1319; f. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;

Product Classification:

Class II

Date Initiated: May 15, 2023

Date Posted: August 9, 2023

Recall Number: Z-2339-2023

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: 9,017 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: DYNDA1224A, UPC Number: 10888277985643; Model Number: DYNDA1224B, UPC Number: 10193489191448. b. Model Number: SPEC0130C, UPC Number: 10193489196641. c. Model Number: MNS11895, UPC Number: 10653160324645. d. Model Number: DYNDH1496, UPC Number: 10193489193947. e. Model Number: DYNDH1319, UPC Number: 10889942795475. f. Model Number: DYNDH1187A, UPC Number: 10889942702633.

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