Philips Therapy Mask 3100 NC/SP CPAP masks lack required magnetic warnings
Philips Respironics is recalling Therapy Mask 3100 NC/SP CPAP masks because they lack warnings about magnetic components that could interfere with implantable medical devices. Approximately 42,954 units have been distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall for a medical device with magnetic components lacking required contraindications for patients with implantable devices. FDA Class I classification mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Philips Respironics is recalling Therapy Mask 3100 NC/SP masks distributed worldwide, including throughout the United States. The recall involves 42,954 units.
The masks contain magnetic components. However, the product lacks contraindications or warnings for patients with implantable medical devices or those with metallic splinters in the eyes. Such patients may be at risk from the magnetic components.
Patients who have implantable medical devices or metallic splinters should contact their healthcare provider or Philips Respironics to discuss whether they can safely use this product.
The recalled product
- Product
- Therapy Mask 3100 NC/SP
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- magnetic-interference
- implantable-device-hazard
- missing-contraindication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- All Units
- Model No.: 1144608
- 1144610
- 1145038
- 1145039
- 1145040
- 1145041
- 1145044
- 1145045
- 1145046
- 1145047
- 1145048
- 1145049
- 1145050
- 1145051
- 1145052
- 1145055
- 1145056
- 1145057
- 1145058
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03