🔍 RecallPedia

Philips Respironics DreamWear Full Face Mask

Class I - Dangerous
🏥 Medical Devices Recalled: September 6, 2022 Philips Respironics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All Units; Model No.: 1133344, 1133345, 1133370, 1133371, 1133372, 1133373, 1133375, 1133376, 1133377, 1133378, 1133380, 1133381, 1133382, 1133383, 1133385, 1133386, 1133387, 1133388, 1133390, 1133391, 1133392, 1133393, 1133395, 1133400, 1133401, 1133405, 1133406, 1133407, 1133408, 1133410, 1133411, 1133412, 1133413, 1133415, 1133416, 1133417, 1133418, 1133423, 1133424, 1133425, 1133427, 1133430, 1133431, 1133432, 1133433, 1133434, 1133435, 1133436, 1133438, 1133450, 1133454, 1135275, 1135276, 1135277, 1135278, 1135327, 1135388, 1135389, 1135390, 1137430, 1137431, 1137437, 1137438, 1137439, 1137440, 1140235, 1143130, 1144347, 1146593, 1146594, 1146595, 1146596, 1146597, 1148363, 1133375RTL, 1133376RTL, 1133377RTL, 1133378RTL, 1133430RTL, 1133431RTL, 1133432RTL, 1133433RTL.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Respironics, Inc.
Reason for Recall:
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Philips Respironics DreamWear Full Face Mask

Product Codes/Lot Numbers:

All Units; Model No.: 1133344, 1133345, 1133370, 1133371, 1133372, 1133373, 1133375, 1133376, 1133377, 1133378, 1133380, 1133381, 1133382, 1133383, 1133385, 1133386, 1133387, 1133388, 1133390, 1133391, 1133392, 1133393, 1133395, 1133400, 1133401, 1133405, 1133406, 1133407, 1133408, 1133410, 1133411, 1133412, 1133413, 1133415, 1133416, 1133417, 1133418, 1133423, 1133424, 1133425, 1133427, 1133430, 1133431, 1133432, 1133433, 1133434, 1133435, 1133436, 1133438, 1133450, 1133454, 1135275, 1135276, 1135277, 1135278, 1135327, 1135388, 1135389, 1135390, 1137430, 1137431, 1137437, 1137438, 1137439, 1137440, 1140235, 1143130, 1144347, 1146593, 1146594, 1146595, 1146596, 1146597, 1148363, 1133375RTL, 1133376RTL, 1133377RTL, 1133378RTL, 1133430RTL, 1133431RTL, 1133432RTL, 1133433RTL.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1781-2022

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