Philips Respironics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1781-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Philips Respironics DreamWear Full Face Mask

Product Classification:

Class I

Date Initiated: September 6, 2022

Date Posted: October 12, 2022

Recall Number: Z-1781-2022

Event ID: 90705

Reason for Recall:

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

Status: Ongoing

Product Quantity: 9,191,280 units

Code Information:

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.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, & District of Columbia. The countries of Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Pier, Miquel., Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Uruguay, Utd. Arab. Emir., Uzbekistan, & Zimbabwe.

Voluntary or Mandated:

Voluntary: Firm initiated