FDA Medical devices recall ·
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1725-2025
- Date
- (initiated April 7, 2025)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 4881 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
A cybersecurity vulnerability was discovered through internal testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Worldwide distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1725-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.