Class I recallOngoing

Welch Allyn Life2000 Compressor recall — FDA event 96611

FDA · FDA event 96611 · Posted May 9, 2025

Published May 9, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

A cybersecurity vulnerability was discovered through internal testing.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Baxter issued an URGENT MEDICAL DEVICE RECALL notice to healthcare providers and patients beginning on 04/07/2025 via USPS first class mail. The notice explained that Baxter was voluntarily initiating a permanent removal of all Life 2000 ventilators currently in use due to a cybersecurity issue and requested the following: Actions to be Taken by DME Providers: 1. Notify your patients using Life2000 ventilators of this recall. 2. Work with patients and prescribers to identify an alternate therapy option. 3. Contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, to coordinate return of Life2000 ventilators and compressors. Actions to be Taken by Healthcare Providers: 1. Locate and discontinue use of all Life2000 ventilators and compressors within your facility. 2. Contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, to coordinate return of Life2000 ventilators and compressors at your facility. Actions to be Taken by Distributors: 1. Please disseminate this information and conduct a user-level recall of the affected product that you distributed to customers. 2. Contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, to coordinate return of Life2000 ventilators and compressors. If you suspect that a device has been exposed to unauthorized personnel, contact Baxter Acute Care Customer Service team. The team can help verify whether the device settings are correct and if the device is performing as expected. The team can be reached by email at HRC_ACCS_Web@baxter.com, or by phone at 800-426-4224, option 2, then option 1. For questions regarding this communication, contact Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1, between the hours of 8:00 am and 6:00 pm Central Time, Monday through Friday.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Welch Allyn Life2000 Compressor by Baxter Healthcare Corporation.

Products affected by FDA event 96611
Model	Description	Lot / serial range	Manufactured	Status
Z-1725-2025	Z-1725-2025	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, UDI/DI 00815410020537 or 00887761978089; 4) BT200007, UDI/DI 00815410020278 or 00887761978089; 5) BT-20-0007, UDI/DI 00815410020278 or 00887761978089; 6) BT200011, UDI/DI 00815410020537 or 00887761978089; 7) BT-20-0011, UDI/DI 00815410020537 or 00887761978089; 8) RMS010118CP, UDI/DI 00815410020537 or 00887761978089.	Not provided in the normalized record	Ongoing
Z-1726-2025	Z-1726-2025	ALL SERIAL NUMBERS: 1) BT-80-0004, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 2) BT-80-0004A, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 3) BT-80-0008, UDI/DI 00887761976283; 4) BT-80-0008A, UDI/DI 00887761976283; 5) RMS010093CP, UDI/DI 00887761978041 or 00815410020537 or 00815410020292.	Not provided in the normalized record	Ongoing

Distribution: Worldwide distribution.
Units affected: See official FDA record
Category: Ventilators

Timeline

Apr 7, 2025
Recall initiated
Date recorded by the FDA.
May 9, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96611
Published: May 9, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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Welch Allyn Life2000 Compressor recall — FDA event 96611

FDA · FDA event 96611 · Posted May 9, 2025

Published May 9, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Welch Allyn Life2000 Compressor by Baxter Healthcare Corporation.

Products affected by FDA event 96611
Model	Description	Lot / serial range	Manufactured	Status
Z-1725-2025	Z-1725-2025	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, UDI/DI 00815410020537 or 00887761978089; 4) BT200007, UDI/DI 00815410020278 or 00887761978089; 5) BT-20-0007, UDI/DI 00815410020278 or 00887761978089; 6) BT200011, UDI/DI 00815410020537 or 00887761978089; 7) BT-20-0011, UDI/DI 00815410020537 or 00887761978089; 8) RMS010118CP, UDI/DI 00815410020537 or 00887761978089.	Not provided in the normalized record	Ongoing
Z-1726-2025	Z-1726-2025	ALL SERIAL NUMBERS: 1) BT-80-0004, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 2) BT-80-0004A, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 3) BT-80-0008, UDI/DI 00887761976283; 4) BT-80-0008A, UDI/DI 00887761976283; 5) RMS010093CP, UDI/DI 00887761978041 or 00815410020537 or 00815410020292.	Not provided in the normalized record	Ongoing

Distribution

Worldwide distribution.

Units affected

See official FDA record

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

Welch Allyn Life2000 Compressor recall — FDA event 96611

Follow Welch Allyn Life2000 Compressor

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Welch Allyn Life2000 Compressor recall — FDA event 96611

Follow Welch Allyn Life2000 Compressor

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline