Philips Respironics DreamWear Full Face Mask Lacks Magnetic Hazard Warning
Philips Respironics is recalling DreamWear Full Face CPAP masks due to missing warnings about magnetic components that may pose risks to patients with implantable devices or metallic eye splinters.
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 per the rubric severity criteria requires a minimum score of 4. The missing warning information about magnetic components poses a potential risk of serious injury or device malfunction in vulnerable patient populations.
Plain-English summary
Philips Respironics, Inc. is recalling the DreamWear Full Face Mask due to the absence of contraindication and warning information regarding magnetic components in the device. The masks lack proper labeling to alert patients with implantable medical devices about potential magnetic hazards, and do not warn about risks associated with metallic splinters in the eyes.
Approximately 9,191,280 units have been distributed worldwide, including throughout all U.S. states and the District of Columbia, as well as to numerous countries internationally.
Patients who use this mask and have an implantable medical device, or who may be at risk from metallic foreign objects in their eyes, should stop using the product and consult their healthcare provider or device manufacturer for guidance. Users should contact Philips Respironics for additional information regarding this recall.
The recalled product
- Product
- Philips Respironics DreamWear Full Face Mask
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- magnetic-component-hazard
- missing-warning-label
- implantable-device-interference
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.: 1133344
- 1133345
- 1133370
- 1133371
- 1133372
- 1133373
- 1133375
- 1133376
- 1133377
- 1133378
- 1133380
- 1133381
- 1133382
- 1133383
- 1133385
- 1133386
- 1133387
- 1133388
- 1133390
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22