Product Recalls

CompassHealth Recall - December 22, 2021

AFFECTED PRODUCTS

  • Carex Brand Bed Support Rail (Model No. P566)
  • Easy Up 2-in-1 Bed Rail (Model No. P569)

This recall involves two Carex brand bed rail models that were sold between November 2012 and December 2021. When attached to an adult's bed, users can become entrapped within the bed rail, or between the rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.

  • pdf logo Recall Notification Letter contains information about the recalled products.

    What do I do if I have an affected product?

    Please immediately stop use of the recalled bed rail and contact Compass Health Brands to obtain a free repair kit for the Bed Support Rail or refund remedy for the Easy Up 2-in-1 Bed Rail. For more information or to participate in the recall, please visit compasshealthbrands.com/product-recall or call (888) 571-2710 from 8 a.m. to 5 p.m. ET, Monday through Friday.


    EcoMed Recall - 8/25/2021

    AFFECTED PRODUCTS

    • Omnisound Gel # 32060 - All Lots
    • EcoGel 200 #45539 - All Lots

    The FDA has determined that all ultrasound gel and lotion manufactured by Eco-Med are at risk for bacterial contamination by the Burkholderia cepacia complex (Bcc). The effects of Bcc infection on people vary widely, ranging from no symptoms at all to serious consequences. Bcc bloodstream infections may result in sepsis and in certain cases possible death.

    pdf logoRecall Notification Letter contains information about the issue and the affected products.

    WHAT DO I DO IF I HAVE AN AFFECTED PRODUCT?

    Immediately stop use of, and destroy and render unusable by disposing along with your general medical waste, all products manufactured by Eco-Med and supplied by Accelerated Care Plus Leasing, Inc. (ACPL).

    Consumers can voluntarily report observed or suspected adverse reactions for human medical products to the FDA with the following link: FDA Website


    Philips Product Recalls - June 14, 2021

    Affected Products

    • E30 (Emergency Use Authorization)
    • DreamStation ASV
    • DreamStation ST, AVAPS
    • SystemOne ASV4
    • C-Series ASV
    • C-Series S/T and AVAPS
    • OmniLab Advanced+
    • SystemOne (Q-Series) DreamStation
    • DreamStation Go
    • Dorma 400
    • Dorma 500
    • REMstar SE Auto
    • Trilogy 100
    • Trilogy 200
    • Garbin Plus, Aeris, LifeVent
    • A-Series BiPAP Hybrid A30 (not marketed in the US)
    • A-Series BiPAP V30 Auto
    • A-Series BiPAP A40 (not marketed in the US)
    • A-Series BiPAP A30 (not marketed in the US)

     

     

    What do I do if I have an affected product?

    Patients may register their product on the Philips website and they will repair or replace the unit with a newly designed model that uses a non-degrading foam.

    For more information, please visit Philips Recall Notification Page

     

    Video Explanation of Product Registration (2:49 minutes)