Respire Medical: Medical Device Recall in 2018 - (Recall #: Z-1948-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Respire Pink+ Hard/Soft Oral Sleep Apnea Device

Product Classification:

Class II

Date Initiated: September 1, 2017

Date Posted: June 6, 2018

Recall Number: Z-1948-2018

Event ID: 80030

Reason for Recall:

Potential for device breakage during use

Status: Terminated

Product Quantity: 29 units

Code Information:

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

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated