FDA Recall Open, Classified

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

Recall: Z-1693-2026 · Initiated February 18, 2026

Recall

Recall Number
Z-1693-2026
Event Number
98529
FEI Number
1417592
Product Code
LRO
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
February 18, 2026
Posted
March 27, 2026
Address
3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

Description

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

Reason

There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 2/18/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-015-FG Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Distribution

US Nationwide distribution in the state of MN.

Quantity

420 units