Respire Pink H/S Oral Sleep Apnea Device Recalled for Breakage Risk
Respire Medical is recalling the Respire Pink H/S Oral Sleep Apnea Device due to a potential for device breakage during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of breakage during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Respire Medical is recalling the Respire Pink H/S Oral Sleep Apnea Device. The recall is issued because of a potential for the device to break during use.
The affected device is identified by Serial Number 46299. The product was distributed nationwide in the United States.
Consumers who have this specific device should stop using it and contact Respire Medical for further instructions.
The recalled product
- Product
- Respire Pink H/S Oral Sleep Apnea Device
- Manufacturer
- Respire Medical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: 46299
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Respire Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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