Agency classClass IOur severity:Severe FDA (Devices)·Z-1726-2025·Announced 2025-05-21

Welch Allyn Life2000 Compressor recalled for cybersecurity vulnerability

Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which per the rubric requires a minimum score of 4. The cybersecurity vulnerability in a life-critical medical device presents significant risk of harm.

Plain-English summary

Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Compressor, a medical device distributed worldwide. The recall affects approximately 4,174 units with product codes BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP.

A cybersecurity vulnerability was discovered through internal testing of the device. The FDA has classified this as a Class I recall, indicating the device has the potential to cause serious injury or death.

Users of the Welch Allyn Life2000 Compressor should contact Baxter Healthcare Corporation for instructions regarding the vulnerability and appropriate remedial action. Healthcare facilities and individuals with affected units should follow the manufacturer's guidance.

The recalled product

Product: Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Compressor
Hazard: cybersecurity-vulnerability
Affected units: 4,174

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 (8)

ALL SERIAL NUMBERS: 1) BT-80-0004
UDI/DI 00887761978041 or 00815410020292 or 00887761978072
2) BT-80-0004A
3) BT-80-0008
UDI/DI 00887761976283
4) BT-80-0008A
5) RMS010093CP
UDI/DI 00887761978041 or 00815410020537 or 00815410020292.

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 →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · cybersecurity vulnerability