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.
What this means for you
Illness, injury, or structural failure has been reported. 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 intended
- Manufacturer
- Draeger, Inc.
- Hazard
- breathing-circuit-defect
- hose-crack
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.
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