# FDA recall Z-1637-2026

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2026-02-18.

## Product

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.  Accessory to Baxter Volara Respiratory Therapy system.

## Reason for recall

Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment.  This correction is providing the home caregiver specific instructions for use.

## Distribution

Florida

## Key facts

- **Recall number:** Z-1637-2026
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-18
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2026

## Citation

> AI Analytics. FDA recall Z-1637-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1637-2026. Source: US FDA. Licensed CC0.

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