Home / Recalls / Respire Medical / Z-1949-2018

Z-1949-2018 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
25 units

Product Description

Respire Pink+ Hard Oral Sleep Apnea Device

Reason for Recall

Potential for device breakage during use

Distribution Pattern

US nationwide distribution.

Code Information

Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268 & 52634

Other recalls by Respire Medical

  • Z-1947-2018 Class II — Respire Pink Series EF+ Oral Sleep Apnea Device. (September 1, 2017)
  • Z-1948-2018 Class II — Respire Pink+ Hard/Soft 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)