Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. 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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model Number (UDI-DI Number): AU2110X15B (606959051980); BL2110X15B (606959055520); BR2110X18B (606959055476); CA2110X12B (606959052307); DE2110X13B (606959054110); DS2110X11B (606959051942); EE2110X15B (606959055544); ES2110X15B (606959054080); EU2110X15B (606959054981); EU2110X19 (606959055537); FP2110X10 (606959062092); FR2110X14B (606959055506); GB2110X15B (606959054127); IA2110X15B (606959055490); IN2110X15B (606959051959); IT2110X21B (606959055421); JP2110X16B (606959051973); KR2110X15B (606959055483); LA2110X15B (606959055452); ND2110X15B (606959055513); PP2110X10 (606959054035); RBRBR2110X18B (606959055476); RDS2110X11B (606959060517); TR2110X15B (606959055551); UDS2110X11B (606959060500). All Serial Numbers.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Respironics, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. 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.

Product Codes/Lot Numbers:

Model Number (UDI-DI Number): AU2110X15B (606959051980); BL2110X15B (606959055520); BR2110X18B (606959055476); CA2110X12B (606959052307); DE2110X13B (606959054110); DS2110X11B (606959051942); EE2110X15B (606959055544); ES2110X15B (606959054080); EU2110X15B (606959054981); EU2110X19 (606959055537); FP2110X10 (606959062092); FR2110X14B (606959055506); GB2110X15B (606959054127); IA2110X15B (606959055490); IN2110X15B (606959051959); IT2110X21B (606959055421); JP2110X16B (606959051973); KR2110X15B (606959055483); LA2110X15B (606959055452); ND2110X15B (606959055513); PP2110X10 (606959054035); RBRBR2110X18B (606959055476); RDS2110X11B (606959060517); TR2110X15B (606959055551); UDS2110X11B (606959060500). All Serial Numbers.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0291-2025

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