The Recall Desk
SevereFDA (Devices)·Z-1782-2022·Announced 2022-10-12

DreamWisp CPAP mask recalled for missing implant safety warnings

Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause 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 applies. The recall involves missing critical safety warnings regarding magnetic components that could interfere with implantable medical devices. No illnesses or injuries have been reported to date.

Plain-English summary

Philips Respironics, Inc. is recalling approximately 930,813 DreamWisp Nasal Masks with Over the Nose Cushion. The recall affects units distributed worldwide, including throughout the United States and internationally. The recall is due to missing contraindication and warning information regarding the mask's magnetic components.

Patients with implantable medical devices such as pacemakers or defibrillators may be at risk from magnetic interference. Additionally, the missing warnings do not address the potential for metallic splinters to enter the eyes. The product lacks appropriate safety warnings for these patient populations.

Patients currently using this mask should consult their healthcare provider before continued use, particularly if they have an implantable medical device or a condition involving metallic foreign bodies in the eyes. Contact Philips Respironics or the FDA for additional information about the recall.

The recalled product

Product
DreamWisp Nasal Mask with Over the Nose Cushion
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Sleep Apnea / CPAP Equipment
Hazard
Affected units
930,813

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.: 1137916
  • 1137918
  • 1137921
  • 1137922
  • 1137923
  • 1137924
  • 1137925
  • 1137926
  • 1137927
  • 1137928
  • 1137929
  • 1137930
  • 1137931
  • 1137932
  • 1137933
  • 1137934
  • 1137935
  • 1137936
  • 1137937

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Philips Respironics, Inc.

See all →

Same hazard · missing warning

See all →