Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Express Dry Seal Chest Drains (Express): 4000-100N DRAIN Recalled by Atrium Medical Corporation Due to Instructions for Use (IFU) for the Atrium Ocean,...

Date: September 18, 2023
Company: Atrium Medical Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Atrium Medical Corporation directly.

Affected Products

Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

Quantity: 48339 cases: 48148 cases US; 193 cases OUS

Why Was This Recalled?

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Atrium Medical Corporation

Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report