CLASS I Device recall · Reported 8 Jun 2022 · FDA Enforcement Report

In-Line ventilator adaptor recalled by Baxter Healthcare

Baxter Healthcare is recalling In-Line ventilator adaptor, distributed nationwide in the US. The recall was initiated on 26 Apr 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesM07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.

Quantity recalled9 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1139-2022
FDA event ID: 90061
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Terminated
Recall initiated: 26 Apr 2022
FDA classified: 30 May 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

26 Apr 2022	Recall initiated by company
30 May 2022	Classified by FDA	+34 days
8 Jun 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

Product as listed by the FDA

In-Line ventilator adaptor

Where it was distributed

US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.

Nationwide Alabama Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Kentucky Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Jersey New Mexico

Questions about this recall

Is In-Line ventilator adaptor recalled?

Yes. Baxter Healthcare recalled In-Line ventilator adaptor on 26 Apr 2022. The recall is Class I and its status is Terminated. Recall number Z-1139-2022.

Why was it recalled?

There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

Which lots are affected?

M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.

Where was it sold?

US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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