Home / Recalls / Respire Medical / Z-1948-2018

Z-1948-2018 Class II Terminated

Recalled by Respire Medical — Brooklyn, NY

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
September 1, 2017
Termination Date
December 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29 units

Product Description

Respire Pink+ Hard/Soft Oral Sleep Apnea Device

Reason for Recall

Potential for device breakage during use

Distribution Pattern

US nationwide distribution.

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

Other recalls by Respire Medical

  • Z-1947-2018 Class II — Respire Pink Series EF+ Oral Sleep Apnea Device. (September 1, 2017)
  • Z-1951-2018 Class II — Respire Pink H/S Oral Sleep Apnea Device (September 1, 2017)
  • Z-1950-2018 Class II — Respire Pink H/S Oral Sleep Apnea Device (September 1, 2017)
  • Z-1949-2018 Class II — Respire Pink+ Hard Oral Sleep Apnea Device (September 1, 2017)