Z-1726-2025Class I

Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A...

Name: Z-1726-2025 Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A...
Creator: Baxter Healthcare Corporation
Published: 2025-04-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-04-07 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP on 2025-04-07. FDA classified it as Class I and gives the reason as "A cybersecurity vulnerability was discovered through internal testing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1726-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-07
Posted: 2025-05-09
Recalling firm: Baxter Healthcare Corporation
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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: A cybersecurity vulnerability was discovered through internal testing.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: 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 [email protected], 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.
Quantity in commerce: 4174 units
Distribution: Worldwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1726-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1725-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09
Z-1726-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09

Product code CBK

K170037Class IIBreathe Technologies Life2000™ Ventilation SystemBreathe Technologies / cleared 2017-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)