Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 888857

FDA device recall Z-1203-2026 · posted 2026-01-28 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

Action taken

On December 26, 2025, the firm notified customers via Urgent Medical Device Product Advisory letters. Customers were instructed to continuing utilizing the CDUs on adult patients (not pediatric patients or infants). The updated IFU for affected product codes can be found at https://www.mycardinalmsds.com/

Root cause

Error in labeling

Status

Open, Classified

Product code

GCX

Quantity affected

1,169,726 units

Distribution

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.

Date initiated

2025-12-26

Date posted

2026-01-28

Location

Waukegan, IL