The Recall Desk
SevereFDA (Devices)·Z-1725-2025·Announced 2025-05-21

Welch Allyn Life2000 Ventilation System Recalled for Cybersecurity Vulnerability

Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system due to a cybersecurity vulnerability discovered through internal testing. The recall affects 4,881 units distributed worldwide.

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: The FDA classified this as a Class I recall. Under the rubric, FDA Class I recalls are never scored below 4, making this a Severe classification.

Plain-English summary

Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system. A cybersecurity vulnerability was discovered through internal testing.

The recall covers 4,881 units that have been distributed worldwide. Multiple product codes are affected, including BT-20-0002, BT-20-0002A, BT-20-0002AP, BT200007, BT-20-0007, BT200011, BT-20-0011, and RMS010118CP.

Consumers who have this ventilation system should contact Baxter Healthcare Corporation for further guidance on the cybersecurity issue and any remedial actions.

The recalled product

Product
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Ventilation Equipment
Hazard
Affected units
4,881

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 (12)

  • ALL SERIAL NUMBERS: 1) BT-20-0002
  • UDI/DI 00815410020537 or 00887761978089
  • 2) BT-20-0002A
  • UDI/DI 00815410020537 of 00887761978089
  • 3) BT-20-0002AP
  • 4) BT200007
  • UDI/DI 00815410020278 or 00887761978089
  • 5) BT-20-0007
  • 6) BT200011
  • 7) BT-20-0011
  • 8) RMS010118CP
  • UDI/DI 00815410020537 or 00887761978089.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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