Respire Pink Series EF+ Oral Sleep Apnea Device Recalled for Breakage Risk
Respire Medical is recalling the Pink Series EF+ Oral Sleep Apnea Device because it may break during use.
What this means for you
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 risk-of-harm product (medical device breakage) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Respire Medical is recalling the Respire Pink Series EF+ Oral Sleep Apnea Device. The recall is due to a potential for the device to break during use.
The affected product is identified by Serial Number 50837. The device was distributed nationwide in the United States.
Consumers with this specific device should stop using it and contact Respire Medical for further instructions.
The recalled product
- Product
- Respire Pink Series EF+ Oral Sleep Apnea Device.
- Manufacturer
- Respire Medical
- Hazard
- Affected units
- 1
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: 50837
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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