Respire Medical: Medical Device Recall in 2018 - (Recall #: Z-1949-2018)

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 Oral Sleep Apnea Device

Product Classification:

Class II

Date Initiated: September 1, 2017

Date Posted: June 6, 2018

Recall Number: Z-1949-2018

Event ID: 80030

Reason for Recall:

Potential for device breakage during use

Status: Terminated

Product Quantity: 25 units

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

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated