FDA Medical devices recall ·
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0296-2025
- Date
- (initiated October 7, 2024)
- Company / brand
- Philips Respironics, Inc.
1001 Murry Ridge Ln, Murrysville, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1,244 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Why was it recalled?
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
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
Model No. SP2100X26B; UDI-DI: 606959057456; All Serial Numbers.
Distribution
Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.
States: Arkansas California Colorado Delaware Idaho Illinois Indiana Massachusetts Maine Montana Pennsylvania Tennessee
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-0296-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.