CPAP Full-Face Mask Recalled for Missing Implantable Device Warnings
Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units 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 medical device recall, which carries a minimum severity of 4. While no deaths or injuries are reported in the source, the missing warnings about magnetic component interactions with implantable devices poses a significant risk to affected patient populations.
Plain-English summary
Philips Respironics is recalling all units of the Amara View Minimal Contact Full-Face Mask due to inadequate labeling and warnings. The Class I recall affects 5,661,639 units distributed worldwide.
The recalled masks lack necessary warnings and contraindications regarding magnetic components for patients with implantable medical devices (such as pacemakers, defibrillators, or cochlear implants) and those with metallic foreign bodies, including splinters, in their eyes. Magnetic fields from the mask's components could potentially interfere with electronic implants or attract metallic objects.
Patients using this mask who have implantable medical devices or metallic objects in their eyes should contact their healthcare provider immediately. Healthcare providers should evaluate patient risk and determine whether alternative CPAP mask options are appropriate.
The recalled product
- Product
- Philips Respironics Amara View Minimal Contact Full-Face Mask
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- device-interference
- metallic-splinter
- mis-labeling
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: 1090602
- 1090603
- 1090604
- 1090622
- 1090623
- 1090624
- 1090641
- 1090642
- 1090643
- 1090644
- 1090651
- 1090652
- 1090653
- 1090654
- 1090662
- 1090663
- 1090664
- 1090670
- 1090696
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