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

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 15, 2026.

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Key facts

Date announced
April 8, 2026
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Baxter healthcare corporation
Category
medical
Source agency
FDA
Announced
April 8, 2026
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

UDI/DI number 00887761984622

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1Stop using the affected product until you verify whether your item is impacted.
  2. 2Check the official recall notice and match your model, lot, or serial details.
  3. 3Follow the official instructions for repair, replacement, refund, or disposal.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
April 8, 2026
Last reviewed by RecallRadar
April 15, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists UDI/DI number 00887761984622.

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the baxter healthcare corporation recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1637-2026&limit=1

Keep browsing with these internal hubs: baxter healthcare corporation recall hub and Medical recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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