The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0295-2025·Announced 2024-11-20

Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure

Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per regulatory classification rules. The hazard—inaccurate flow measurements in a life-critical ventilator—poses significant risk to patient safety, even though no illnesses or deaths have been reported.

Plain-English summary

Philips Respironics, Inc. is recalling the Garbin Evo ventilator (Model LD2110X23B). This medical device is designed 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.

A defect in certain device configurations has been identified: the in-line nebulizer setup can allow aerosol deposits to accumulate on the device's internal flow sensor. This accumulation can cause the sensor to provide inaccurate flow measurements, potentially affecting the accuracy of respiratory support delivered to patients.

Approximately 1,322 units have been distributed worldwide, including throughout the United States and more than 70 additional countries. The recall affects all serial numbers of Model LD2110X23B (UDI-DI: 606959057432).

The recalled product

Product
Garbin Evo. Model Number: LD2110X23B. 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.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator / Respiratory Equipment
Hazard
Affected units
1,322

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No. LD2110X23B
  • UDI-DI: 606959057432
  • All Serial Numbers.

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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