The Recall Desk
CriticalFDA (Devices)·Z-0884-2025·Announced 2025-01-22

Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability

The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification is the criterion for Critical severity under the recall rubric. Class I indicates a reasonable probability the product could cause serious adverse health consequences or death.

Plain-English summary

The Welch Allyn Life 2000 Ventilation System (manufactured by Baxter Healthcare Corporation) is being recalled due to a battery charger defect. The defect could lead to an audible and visual alarm, and if this alarm is engaged, the ventilator becomes inoperable.

This is a Class I recall affecting 187 units that were distributed nationwide in the United States. The affected units can be identified by serial numbers in association with UDI/DI code 00887761978201.

If you own or use an affected Life 2000 Ventilation System, contact Baxter Healthcare Corporation or your healthcare provider immediately for guidance. Do not use a unit if the alarm has engaged or if you believe your unit may be affected.

The recalled product

Product
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Manufacturer
Baxter Healthcare Corporation
Hazard
  • ventilator-malfunction
  • battery-charger-defect
  • alarm-failure

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 (20)

  • UDI/DI 00887761978201
  • Serial Numbers: 124080000663
  • 124020000164
  • 124020000165
  • 124020000166
  • 124020000167
  • 124020000168
  • 124020000169
  • 124020000170
  • 124020000171
  • 124020000172
  • 124020000173
  • 124020000174
  • 124020000175
  • 124020000176
  • 124080000659
  • 124080000661
  • 124080000662
  • 124080000666
  • 124080000667

Distribution

Distributed nationwide across the United States.