Agency classClass IOur severity:Critical FDA (Devices)·Z-0591-2026·Announced 2025-12-17

Ventilator airway connectors recalled after cracks formed in the hose

Draeger is recalling 191,470 ErgoStar CM 45 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.

Plain-English summary

The Draeger ErgoStar CM 45, model MP01845, is being recalled. The device is an airway connector for conduction of respiratory gases between the breathing system and the patient interface, such as an endotracheal tube mask, of a mechanically ventilated patient.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

The recall covers 191,470 units carrying UDI 04048675420729, across all lot numbers. Distribution was worldwide, including California, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Wisconsin domestically, and a wide range of other countries. The FDA has classified the action as Class I, its most serious category.

Facilities should quarantine affected stock immediately and follow Draeger's instructions.

The recalled product

Product: ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Manufacturer: Draeger, Inc.
Category: Medical Device — Ventilation accessory
Hazard: cracking
airway-circuit
ventilation
class-i
Affected units: 191,470

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/Catalog Number: MP01845
UDI Number: 04048675420729
Lot numbers: All lot numbers

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 4 recalled by Draeger, 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 4 products in this recall →

Same manufacturer · Draeger, Inc.

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Same hazard · cracking