Hello Respire Medical Customers,
Here at Respire, patient safety is our number one priority. On 5/23/2018 we conducted a recall of Pink Series appliances with the knowledge of the FDA because of reported breakages of the appliances’ arms. This recall only affects the below serial numbers:
Respire Pink H/S; Serial Numbers: 46299, 50317
Respire Pink Series EF+ Hard; Serial Number: 50837
Respire Pink+ Hard/Soft; Serial Numbers: 51366, 51439, 51368, 51577, 51303, 52409, 51985, 51796, 51709, 51744, 51560, 51321, 51545, 51437, 51571, 51576, 51438, 51566, 51509, 51629, 51502, 51409, 51307, 51218, 51154, 51001, 51220, 51153, & 50807
Respire Pink+ Hard; Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268, & 52634
Only the above 2 original Pink Series devices (46299, and 50317) are affected by the recall. The remaining 55 recalled devices are Pink+ appliances. This recall does not affect any of the Respire Blue Series appliances. We recommend you discontinue using the above listed appliances if you have one, and return it to your dentist so that it can be replaced for free with an original Pink Series device that has the original Scheu arms. If you have any questions concerning the unit you have please contact us. Respire Medical has a firm commitment to customer satisfaction and patient safety.
Respire was formed in March 2010 with a business model of providing a range of top quality, functional devices to make sleep apnea treatment available to more people than ever before.
Following the initial years of growth the company has never been in a better position to capitalize on the opportunities in the market. Respire has built a solid operational foundation and has a strong management team to create products and services that drive growth in the marketplace.
Respire was recently acquired by Whole You, Inc., a Mitsui Chemicals Company. Whole You brings a wealth of resources and knowledge to help drive us forward in the next phase of our growth.
This new partnership will help provide you with industry leading products and services over the coming years as we continue to build our relationship with you.