Agency classClass IOur severity:Critical FDA (Food)·H-0252-2026·Announced 2025-12-17

ErgoStar CM 40 airway connectors recalled after cracks formed in the hose

Draeger is recalling 14,420 ErgoStar CM 40 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 (Food): 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 40, model MP01840, 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 14,420 units carrying UDI 04048675420736, 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: Deep-brand Premium Select Chikoo Slices KEEP FROZEN Net Wt. 12 oz. (340 g)
Manufacturer: CHETAK NEW YORK LLC
Category: Medical Device — Ventilation accessory
Hazard: cracking
airway-circuit
ventilation
class-i
Affected units: 3,509,532

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 (20)

Lot: 24356
24358
24359
24361
24363
24366
25002
25043
25044
25045
25046
25048
25050
25051
25052
25053
25055
25057
25059
25060

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · CHETAK NEW YORK LLC

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Same hazard · cracking