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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Respire Medical: Potential for device breakage during use

Agency Publication Date: May 29, 2018
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Affected Products

Product: Respire Pink Series EF+ Oral Sleep Apnea Device.

Serial Number: 50837

Product: Respire Pink+ Hard/Soft Oral Sleep Apnea Device

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

Product: Respire Pink+ Hard Oral Sleep Apnea Device

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

Product: Respire Pink H/S Oral Sleep Apnea Device

Serial Number: 46299

Product: Respire Pink H/S Oral Sleep Apnea Device

Serial Number: 50317

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80030
Status: Resolved
Manufacturer: Respire Medical
Manufactured In: United States
Units Affected: 3 products (1 unit; 29 units; 25 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.