Respire Pink+ Oral Sleep Apnea Device Recalled for Breakage Risk
Respire Medical is recalling 29 units of the Pink+ Hard/Soft Oral Sleep Apnea Device due to a potential for device breakage 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 is classified as FDA Class II and involves a risk-of-harm product (device breakage) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Respire Medical is recalling 29 units of the Respire Pink+ Hard/Soft Oral Sleep Apnea Device. The recall was initiated because of a potential for the device to break during use.
The affected devices were distributed nationwide in the United States. The recall covers specific serial numbers, including 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, and 50807.
Consumers who possess one of these specific serial numbers should stop using the device and contact Respire Medical for instructions on how to proceed.
The recalled product
- Product
- Respire Pink+ Hard/Soft Oral Sleep Apnea Device
- Manufacturer
- Respire Medical
- Category
- Medical Device — Oral Appliance
- Hazard
- Affected units
- 29
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 (20)
- Serial Numbers: 51366
- 51439
- 51368
- 51577
- 51303
- 52409
- 51985
- 51796
- 51709
- 51744
- 51560
- 51321
- 51545
- 51437
- 51571
- 51576
- 51438
- 51566
- 51509
- 51629
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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