🔍 RecallPedia

DreamWisp Nasal Mask with Over the Nose Cushion

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.: 1137916, 1137918, 1137921, 1137922, 1137923, 1137924, 1137925, 1137926, 1137927, 1137928, 1137929, 1137930, 1137931, 1137932, 1137933, 1137934, 1137935, 1137936, 1137937, 1137938, 1137939, 1137940, 1137941, 1137942, 1137943, 1137944, 1137945, 1137946, 1137947, 1137948, 1137949, 1137950, 1137951, 1137953, 1137954, 1137955, 1137964, 1137965, 1137966, 1139332, 1139333, 1139334, 1139335, 1139336, 1144344, 1144345, 1144346, 1144502, 1148409, 1148410, 1148411, 1148913, 1148914, 1148915, 1148916, 1148917, 1137916RTL, 1137942AP, 1137942CE, 1137942RC, 1137943AP, 1137943CE, 1137943RC, 1137944AP, 1137944CE, 1137944RC, 1137945AP, 1137945CE, 1137945RC, 1137946AP, 1137946CE, 1137946RC.
  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:

DreamWisp Nasal Mask with Over the Nose Cushion

Product Codes/Lot Numbers:

All Units; Model No.: 1137916, 1137918, 1137921, 1137922, 1137923, 1137924, 1137925, 1137926, 1137927, 1137928, 1137929, 1137930, 1137931, 1137932, 1137933, 1137934, 1137935, 1137936, 1137937, 1137938, 1137939, 1137940, 1137941, 1137942, 1137943, 1137944, 1137945, 1137946, 1137947, 1137948, 1137949, 1137950, 1137951, 1137953, 1137954, 1137955, 1137964, 1137965, 1137966, 1139332, 1139333, 1139334, 1139335, 1139336, 1144344, 1144345, 1144346, 1144502, 1148409, 1148410, 1148411, 1148913, 1148914, 1148915, 1148916, 1148917, 1137916RTL, 1137942AP, 1137942CE, 1137942RC, 1137943AP, 1137943CE, 1137943RC, 1137944AP, 1137944CE, 1137944RC, 1137945AP, 1137945CE, 1137945RC, 1137946AP, 1137946CE, 1137946RC.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1782-2022

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