Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CA

FDA device recall Z-1562-2026 · posted 2026-03-12 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

Reason for recall

The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

Action taken

An URGENT MEDICAL DEVICE PRODUCT ADVISORY notification dated 1/30/25 was sent to customers. REQUIRED ACTION: 1.Actions to be taken are indicated on the attached recall notification from Cardinal Health. 2.Please use the link and the information below to complete your response form stating that you have received, read, understand and performed any actions as specified in the notification from CardinalHealth. Website link: https://recalls.medline.com Recall Reference #: R-26-006-FGX2 Recall Code: 3.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 communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Root cause

Error in labeling

Status

Open, Classified

Product code

OEZ

Quantity affected

2894 units

Distribution

Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.

Date initiated

2026-01-30

Date posted

2026-03-12

Location

Northfield, IL