November 25, 2024: React Health Product Recall (Ultra-Soft 12' Nasal Oxygen Cannula Lot Code 20170403)
The reason for this recall is that 3B Medical, Inc., has discovered the recalled devices -- Ultra-Soft 12' Oxygen Cannulas Part O2U2012, Lot Code 20170403 -- were shipped past the manufacturer's expiration date of April 2022. The manufacturer has indicated that expiration date is the date to which the cannula material would remain stable. After the expiration date, users may observe the cannula is subject to discoloring or cracking. To date, 3B Medical, Inc., has not received any reports of death, serious injury, or harm related to this issue.
Patients in possession of recalled devices should discontinue use and contact the vendor where they were purchased for a replacement. Adverse events, reactions, or quality issues experienced with the use of these devices may be reported to 3B Medical, Inc., dba React Health or via the FDA’s MedWatch Adverse Event Reporting program.
March 01, 2024: Sleepnet Medical Device Recall (Sleepnet Masks with Magnets)
Sleepnet Corporation is voluntarily recalling masks with magnets which are intended to be used with positive airway pressure devices such as CPAP or bi-level. Masks included in the recall are the Mojo Full Face Vented Mask, Mojo Full Face Non Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non Vented Mask, Mojo 2 Full Face AAV Non Vented Mask, iQ 2 Nasal Mask, and the Phantom 2 Nasal Mask.
This recall is being initiated based on information obtained from post market surveillance indicating a possible risk to patients and anyone in close physical contact with the mask, having an active medical implant or metallic implant that can be impacted by the magnetic field. The existing contraindications and warnings are being revised as a proactive measure to provide additional safety information to patients and healthcare professionals. To date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets. To learn more about the recall and what steps you should take please click the link below.
- Read SleepNet's Urgent Medical Device Recall Announcement
- Direct Questions About this Recall to Sleepnet at 1-800-742-3646
- Visit the Sleepnet Website
November 20, 2023: ResMed Urgent Field Safety Notice (ResMed Masks with Magnets - Potential Magnetic Interference with Certain Medical Devices)
ResMed is providing patients with important information regarding their masks with magnets, which may interact with some implants or certain medical devices. In response to new information from latest industry practices and global safety data, ResMed is updating the Contraindications and Warnings in their User Guides to instruct patients on the safe use of ResMed masks with magnets. Affected masks include: AirFit F20, AirFit F20 for Her, AirTouch F20, AirTouch F20 for Her, AirFit F30, AirFit F30i, AirFit N10, AirFit N10 for Her, AirFit N20, AirFit N20 for Her, AirTouch N20, AirTouch N20 for Her, AirFit F20 NV.
- Read ResMed's Updated Information on Masks with Magnets for Mask Users
- Download a Copy of ResMed's Urgent Field Safety Notice (Masks with Magnets)
- Direct Questions About this Correction to ResMed
- Visit the ResMed Website
November 16, 2023: SoClean Urgent Medical Device Field Correction (SoClean 2 and SoClean 3 Automated Supplemental Sleep Equipment Maintenance Systems)
SoClean is conducting a voluntary field action intended to update and clarify the user manuals for all units of the SoClean2 and SoClean3. This voluntary field correction does not require you to stop using or return your SoClean unit. SoClean is revising its labeling to incorporate: (i) additional warnings and contraindications; and (ii) proper and consistent device set-up instructions including use of a hose and mask adapter, thereby reducing potential risks associated with the previous device design and labeling.
- Read SoClean's Urgent Medical Device Field Correction Online
- Download a Copy of SoClean's Urgent Medical Device Field Correction
- Direct Recall Questions to SoClean at 866-501-3705
- Visit the SoClean Website
September 2022: Philips Urgent Medical Device Correction (Masks with Magnets)
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. These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body. To learn more about this Urgent Medical Device Correction use the links below.
- Read the Full Urgent Medical Device Correction Notice Online
- Download a Copy of Philips Urgent Medical Device Correction
- Download Philips Urgent Medical Device Correction FAQ
- Direct Questions About this Correction to Philips at 877-387-3311
- Visit the Philips Respironics Website
June 2021: Philips Voluntary Recall Information (Various Devices Including DreamStation)
After discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only) for various Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator) devices. For information on the recall, the registration process, a complete list of impacted products, and potential health risks, use the links below:
- Philips Respironics Sleep & Respiratory Care Devices Voluntary Recall Information
- Direct Recall Questions to Philips at 877-907-7508
- Click Here to Register Your Device for Recall Service
- Visit the Philips Respironics Website
