Respire Pink+ Hard/Soft Oral Sleep Apnea Device recallZ-1948-2018 · Respire Medical · initiated Sep 1, 2017
Class II Terminated All recalls posted in May 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Respire Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for device breakage during use
FDA root cause category: Device Design
What the company is doing
On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions: - Immediately examine your inventory, discontinue use and quarantine product subject to recall. - In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice. - Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge. Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.
Recall details
- Recall number
- Z-1948-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 1, 2017
- Posted by the FDA
- May 29, 2018
- Recalling firm
- Respire Medical
- Quantity
- 29 units
- Product code
- LRK
- FDA submissions
- K150572
- Distribution
- US nationwide distribution.
Product description
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Code information (models, lots, serial numbers)
Serial Numbers: 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 & 50807
Other devices under the same FDA submission
1 device cleared under K150572 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Pink Series - EF SP030USRespire Medical Holdings LLC · Device, Anti-Snoring1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 80030).
- Z-1947-2018 · TerminatedRespire Pink Series EF+ Oral Sleep Apnea Device.
- Z-1949-2018 · TerminatedRespire Pink+ Hard Oral Sleep Apnea Device
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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