# FDA recall Z-1950-2018

> **Respire Medical** · Class II · device recall initiated 2017-09-01.

## Product

Respire Pink H/S Oral Sleep Apnea Device

## Reason for recall

Potential for device breakage during use

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-1950-2018
- **Recalling firm:** Respire Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-01
- **Report date:** 2018-06-06
- **Termination date:** 2019-12-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2018

## Citation

> AI Analytics. FDA recall Z-1950-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1950-2018. Source: US FDA. Licensed CC0.

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