Updates & Recalls
Updates
Monkeypox (August 2022)
According to the Centers for Disease Control and Prevention (CDC), monkeypox disease is rare, but there is a growing outbreak throughout the world causing concern.
Learn more about monkeypox.
Recalls of Medical Products
Medical products can be recalled for a number of different reasons. It is important that you are aware of recalls for any equipment you may have. The best way to do this is to fill out and submit any equipment registration forms you get with the equipment so the manufacturer will have your contact information in their database. You should also look for and review communications from the vendor who provided your equipment. National Jewish Health does not provide medical equipment so we may not have the most up to date information on product recalls.
If you have questions about the medical equipment that you have, please contact the vendor who provided your equipment. You can also access recall information from the Food and Drug Administration (FDA) website. Below is a link to this site.
Recalls, Market Withdrawals, & Safety Alerts | FDA
ResMed Sleep Masks (November 2023)
On November 20, 2023, ResMed issued an Urgent Field Safety Notice for ResMed Masks with Magnets for potential magnetic interference with some implants or certain medical devices.
The masks that are affected are listed below. If you are using one of these ResMed masks, please see their patient letter for more information.
Mask type | Affected masks |
Full face mask | AirFit F20, AirFit F20 for Her AirTouch F20, AirTouch F20 for Her AirFit F30 AirFit F30i
|
Nasal mask | AirFit N10, AirFit N10 for Her AirFit N20, AirFit N20 for Her AirTouch N20, AirTouch N20 for Her Non vented mask AirFit F20 NV |
AKORN Products Recall (May 2023)
Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has issued a voluntary recall of various products.
Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8 a.m. – 5 p.m. CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm. Select “Consumer/Patient (FDA Form 3500B).”
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Healthcare providers with questions can contact Akorn at 800-932-5676, Monday – Friday, 8 a.m. – 5 p.m., Central time. A qualified medical professional will return the call within one business day.
Philips Respironics Sleep Masks (September 2022)
Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.
National Jewish Health does not currently supply these Philips Respironics masks. However, we do not know what mask you are using. Please review this letter and if you have concerns, please contact your Durable Medical Equipment (DME) provider.
Read important recall information from Philips Respironics.
Philips Respironics (June 2021)
Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update.
View National Jewish Health correspondence to patients affected by the recall.