MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2310-2023)

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. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;

Product Classification:

Class II

Date Initiated: May 15, 2023

Date Posted: August 9, 2023

Recall Number: Z-2310-2023

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: 4,618 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: DYNJ906905B, UPC Number: 019348988494. b. Model Number: CDS840215O, UPC Number: 019348944899. c. Model Number: DYNJ906905A, UPC Number: 019348939112. d. Model Number: DYNDH1187A, UPC Number: 088994270263.

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