The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1783-2022·Announced 2022-10-12

Wisp and Wisp Youth nasal masks recalled for missing implanted device warnings

Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as a Class I recall. The rubric requires a minimum score of 4 for FDA Class I recalls. Although no illnesses have been reported, the missing safety warnings regarding magnetic interference with implanted devices and eye injury risk from metallic splinters constitute serious potential health hazards.

Plain-English summary

Philips Respironics is recalling all units of Wisp and Wisp Youth nasal masks due to the lack of contraindication warnings and adequate labeling. The masks contain magnetic components that may affect patients with implanted medical devices such as pacemakers, and may contain metallic splinters that could cause eye injury.

The recall affects millions of units distributed worldwide, including throughout all U.S. states and many countries. The FDA has classified this as a Class I recall, its most serious designation, reflecting the seriousness of the potential health hazard.

Patients with implanted medical devices who currently use these masks should contact their healthcare provider to discuss risks. All consumers should contact Philips Respironics for information about the recall and available alternatives.

The recalled product

Product
Wisp and Wisp Youth Nasal Mask
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — CPAP Mask
Hazard
Affected units
6,237,558

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.: 1094050
  • 1094051
  • 1094053
  • 1094060
  • 1094061
  • 1094062
  • 1094070
  • 1094071
  • 1094072
  • 1094073
  • 1109298
  • 1113954
  • 1117119
  • 1118060
  • 1118061
  • 1118062
  • 1118063
  • 1118064
  • 1118065

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 →

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Same manufacturer · Philips Respironics, Inc.

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