Philips Respironics, Inc. Therapy Mask 3100 NC/SP Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Therapy Mask 3100 NC/SP
Brand
Philips Respironics, Inc.
Lot Codes / Batch Numbers
All Units, Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917.
Products Sold
All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917.
Philips Respironics, Inc. is recalling Therapy Mask 3100 NC/SP due to No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Recommended Action
Per FDA guidance
The firm started notifying customers of this recall event via telephone on 9/6/2022. Additionally, customers were mailed an URGENT Medical Device Correction Letter dated 9/9/2022 that communicates that the firm is updating the Contraindications and Warning language for the Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, and Therapy Mask 3100 NC/SP due to the presence of magnets that may affect implanted medical devices and metallic splinters in the eye. All units of these masks are subject to this recall action. If a patient, a household member, caregiver, or bedpartner that is in close vicinity to patients using the mask is equipped with one of the medical devices or metallic splinters indicated in the updated Contraindications and Warning language, patients are to stop use of the affected mask and properly dispose of it once an alternative mask without magnets has been obtained after consultation with their healthcare provider. If the patient or others around them does not possess an implanted device or metal splinters included in the updated contraindications language, no action is needed. Users and those in the vicinity of the patient while using the mask must ensure the mask is kept at least six inches from medical implants and metallic splinters in the eye. Customers with any questions are to contact Philips Customer Care Solutions at 1-800-345-6443. The firm issued a press release on 9/6/22 and can be found at the following link: https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220906-philips-respironics-alerts-customers-worldwide-of-updated-instructions-and-labeling-of-specific-sleep-therapy-masks-that-contain-magnetic-headgear-clips-due-to-potential-risk-of-serious-injury.html. A second Urgent Medical Device Correction Letter was sent to customers on 12/1/2022. Should DMEs, distributors, and prescribers decide to continue distributing masks and mask accessories with magnet
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026