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.

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold Recalled by Galemed Corporation Due to Reports of pressure relief manifold venting gas below...

Date: May 30, 2019
Company: Galemed Corporation
Status: Terminated
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 Galemed Corporation directly.

Affected Products

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

Quantity: 12000

Why Was This Recalled?

Reports of pressure relief manifold venting gas below the standard pressure.

Where Was This Sold?

This product was distributed to 2 states: NV, NC

Affected (2 states)Not affected

About Galemed Corporation

Galemed Corporation has 3 total recalls tracked by RecallDetector.

Related Recalls

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