Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Carina Sub-Acute Care Ventilator Recalled by Draeger Medical, Inc. Due to Presence of polyether polyurethane (PE-PUR) and emission of...

Date: July 12, 2023
Company: Draeger Medical, Inc.
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 Draeger Medical, Inc. directly.

Affected Products

Carina Sub-Acute Care Ventilator

Quantity: 11,621 units

Why Was This Recalled?

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Draeger Medical, Inc.

Draeger Medical, Inc. has 78 total recalls tracked by RecallDetector.

Related Recalls

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