CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report

Respire Pink+ Hard/Soft Oral Sleep Apnea Device recalled

Respire Medical is recalling Respire Pink+ Hard/Soft Oral Sleep Apnea Device, distributed nationwide in the US. The recall was initiated on 1 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled29 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1948-2018
FDA event ID: 80030
Recalling firm: Respire Medical, Brooklyn, NY
Classification: Class II
Status: Terminated
Recall initiated: 1 Sep 2017
FDA classified: 29 May 2018
Reported: 6 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Sep 2017	Recall initiated by company
29 May 2018	Classified by FDA	+270 days
6 Jun 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for device breakage during use

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Respire Pink+ Hard/Soft Oral Sleep Apnea Device

Where it was distributed

US nationwide distribution.

Nationwide

Questions about this recall

Is Respire Pink+ Hard/Soft Oral Sleep Apnea Device recalled?

Yes. Respire Medical recalled Respire Pink+ Hard/Soft Oral Sleep Apnea Device on 1 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-1948-2018.

Why was it recalled?

Potential for device breakage during use

Which lots are affected?

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

Where was it sold?

US nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Respire Medical

All 5

Reported	Class	Recall	Company	Reason	Where
6 Jun 2018Device	CLASS II	Respire Pink+ Hard Oral Sleep Apnea Device recalled by Respire Medical	Respire Medical	Device Malfunction	Nationwide
6 Jun 2018Device	CLASS II	Respire Pink H/S Oral Sleep Apnea Device recalled by Respire Medical	Respire Medical	Device Malfunction	Nationwide
6 Jun 2018Device	CLASS II	Respire Pink H/S Oral Sleep Apnea Device recalled by Respire Medical	Respire Medical	Device Malfunction	Nationwide
6 Jun 2018Device	CLASS II	Respire Pink Series EF+ Oral Sleep Apnea Device recalled	Respire Medical	Device Malfunction	Nationwide

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