Agency classClass IOur severity:Severe FDA (Devices)·Z-1495-2025·Announced 2025-04-09

Draeger Anesthesia Circuit Kit Flex 1 recalled for potential hose cracks

Draeger, Inc. is recalling Anesthesia Circuit Kit Flex 1 devices nationwide and internationally due to potential cracks in the breathing circuit hose that conducts anesthesia gases.

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 medical device recall. Class I recalls represent situations where use of the product may cause or contribute to serious injury or death. Although no illnesses or injuries have been reported, the potential for cracks in a breathing circuit used in anesthesia constitutes a serious hazard that warrants the minimum Class I classification score of 4 (Severe).

Plain-English summary

Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 1 (Model MP02737) due to the potential for cracks to form in the breathing circuit hose. The product conducts medical gases between anesthesia machines and patients and is intended for single use.

This Class I recall involves all lot numbers of the affected model. Approximately 3,140 units were distributed, including nationwide domestic distribution in the United States and international distribution to 22 countries across Europe, Asia, Africa, and other regions.

Healthcare facilities and providers that have received this equipment should contact Draeger, Inc. for further information and instructions regarding the recall.

The recalled product

Product: Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is…
Manufacturer: Draeger, Inc.
Category: Medical Device — Anesthesia Equipment
Hazard: breathing-circuit-defect
hose-crack
Affected units: 3,140

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: MP02737
UDI Number 04048675389620
All lot numbers.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Draeger, Inc.

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