Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0046-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

Product Classification:

Class I

Date Initiated: September 12, 2024

Date Posted: October 30, 2024

Recall Number: Z-0046-2025

Event ID: 95398

Reason for Recall:

The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.

Status: Ongoing

Product Quantity: 10,957 units

Code Information:

UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated