FDA Medical Device Recalls (openFDA)
Respire Medical: Respire Pink+ Hard Oral Sleep Apnea Device
- Recall number
- Z-1949-2018
- Recalling firm
- Respire Medical
- Product
- Respire Pink+ Hard Oral Sleep Apnea Device
- Status
- Terminated
- Initiated
- 2017-09-01
- Posted
- 2018-05-29
- Terminated
- 2019-12-09
- Reason
- Potential for device breakage during use
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 25 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268 & 52634
- 510(k) numbers
- ["K150572"]
- PMA numbers
- not on file
- Product code
- LRK
- Firm FEI
- 3008937561
- Firm city
- not on file
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28