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Life2000 recallZ-1726-2025 · Baxter Healthcare Corporation · initiated Apr 7, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A cybersecurity vulnerability was discovered through internal testing.

FDA root cause category: Software in the Use Environment

What the company is doing

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.

Recall details

Recall number
Z-1726-2025
Status
Open, Classified
Initiated by the company
Apr 7, 2025
Posted by the FDA
May 9, 2025
Recalling firm
Baxter Healthcare Corporation
Quantity
4174 units
Product code
CBK
FDA submissions
K170037
Distribution
Worldwide distribution.

Product description

Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96611).

Sources and updates

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