Recall Z-1951-2018 ยท LRK Device, Anti-Snoring
Respire Medical
Respire Pink H/S Oral Sleep Apnea Device
| Date | May 29, 2018 (initiated Sep 1, 2017) |
| Status | Terminated |
| 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 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.