The Recall Desk
SevereFDA (Devices)·Z-0886-2025·Announced 2025-01-22

Welch Allyn Life2000 Ventilator Battery Charger Malfunction Recall

Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls must be scored no lower than 4. No deaths or serious injuries have been reported. The hazard—a battery charger malfunction that renders a critical life-support device inoperable—qualifies as severe rather than critical.

Plain-English summary

Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation System (REF BT-20-0002AP) due to a defect in the ventilator battery charger.

The battery charger can trigger an audible and visual alarm that causes the ventilator to become inoperable. When the alarm engages, the device cannot function to deliver ventilation support.

This recall affects units distributed nationwide in the United States. The affected unit serial number is 122010001081.

If you have a Welch Allyn Life2000 Ventilation System, contact Baxter Healthcare Corporation or the FDA for instructions on replacement or repair of the affected device.

The recalled product

Product
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Respiratory / Ventilation
Hazard
  • device-inoperability
  • alarm-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00887761981638
  • Serial Numbers: 122010001081

Distribution

Distributed nationwide across the United States.

Related recalls

Same category