Respire Pink H/S Oral Sleep Apnea Device Recalled for Breakage Risk
Respire Medical is recalling the Pink H/S 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 medical device with a risk of harm (breakage) where no specific injuries or illnesses have been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Respire Medical is recalling the Respire Pink H/S Oral Sleep Apnea Device. The recall was initiated due to a potential for the device to break during use.
The affected device is identified by Serial Number 50317. The product was distributed nationwide in the United States.
Consumers should stop using the device and contact Respire Medical for further instructions.
The recalled product
- Product
- Respire Pink H/S Oral Sleep Apnea Device
- Manufacturer
- Respire Medical
- Category
- Medical Device — Oral Appliance
- 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: 50317
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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