CPAP Mask Recall Due to Missing Safety Warnings for Magnetic Components
Philips Respironics is recalling DreamWear Full Face Masks because they lack warnings about magnetic components that could interfere with implantable devices and risk eye injury from metallic 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: FDA Class I recall classification mandates a minimum severity score of 4. The recall addresses missing safety warnings for magnetic components affecting implantable devices and metallic splinter eye injury risk.
Plain-English summary
Philips Respironics, Inc. is recalling DreamWear Full Face Mask units worldwide. The recall involves approximately 9,191,280 units distributed across the United States and internationally.
The masks are being recalled for failing to provide required safety contraindications and warnings regarding magnetic components. The missing information concerns the potential effects of magnetic components on patients with implantable medical devices and the risk of metallic splinters in the eyes.
Consumers, particularly those with implantable medical devices, should consult their healthcare provider regarding these masks. The FDA has classified this as a Class I recall.
The recalled product
- Product
- Philips Respironics DreamWear Full Face Mask
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — CPAP Mask
- Hazard
- missing-contraindication
- magnetic-interference
- metallic-splinter
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.
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