Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-1138-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

In-Line ventilator adaptor

Product Classification:

Class I

Date Initiated: April 26, 2022

Date Posted: June 8, 2022

Recall Number: Z-1138-2022

Event ID: 90061

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.

Status: Terminated

Product Quantity: 259 units

Code Information:

M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated