Respire Pink+ Hard Oral Sleep Apnea Device Recalled for Breakage Risk
Respire Medical is recalling 25 units of the Pink+ Hard 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 risk-of-harm product (medical device breakage) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Respire Medical is recalling 25 units of the Respire Pink+ Hard Oral Sleep Apnea Device. The recall is being conducted because of a potential for the device to break during use.
The affected units were distributed nationwide in the United States. The specific serial numbers for the recalled devices are 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268, and 52634.
Consumers should check their device serial numbers against the list provided. If the device is affected, they should stop using it and contact Respire Medical for instructions on how to proceed.
The recalled product
- Product
- Respire Pink+ Hard Oral Sleep Apnea Device
- Manufacturer
- Respire Medical
- Category
- Medical Device — Oral Appliance
- Hazard
- Affected units
- 25
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: 51447
- 51460
- 51612
- 51318
- 51320
- 51839
- 51714
- 51909
- 51720
- 51397
- 51498
- 51413
- 51581
- 51479
- 51503
- 51496
- 51163
- 51084
- 50472
- 46747
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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