Z-1950-2018Class II

Respire Pink H/S Oral Sleep Apnea Device

Name: Z-1950-2018 Respire Pink H/S Oral Sleep Apnea Device
Creator: Respire Medical
Published: 2017-09-01
License: https://open.fda.gov/license/

Respire Medical / initiated 2017-09-01 / Terminated / root cause: design

FDA source

Respire Medical began a recall of Respire Pink H/S Oral Sleep Apnea Device on 2017-09-01. FDA classified it as Class II and gives the reason as "Potential for device breakage during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1950-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Posted: 2018-05-29
Terminated: 2019-12-09
Recalling firm: Respire Medical
Product: Respire Pink H/S Oral Sleep Apnea Device
Product code: LRK Device, Anti-Snoring
Reason for recall: Potential for device breakage during use
Root cause tag: design
FDA 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.
Distribution: US nationwide distribution.
Product codes and lots: Serial Number: 46299

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1950-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1947-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29
Z-1948-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29
Z-1949-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29
Z-1950-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29
Z-1951-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29

Product code LRK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)