Agency classClass IOur severity:Severe FDA (Devices)·Z-1499-2025·Announced 2025-04-09

Anesthesia Circuit Kit Flex EPA recalled due to breathing hose cracking

Draeger is recalling the Anesthesia Circuit Kit Flex EPA due to the potential for cracks to form in the breathing circuit hose. Approximately 13,620 units have been distributed domestically and internationally. Users should discontinue use of affected units immediately.

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: FDA Class I recalls require minimum severity score of 4 per the severity rubric. The potential for structural cracking in a breathing circuit component used during anesthesia delivery warrants a Severe classification.

Plain-English summary

The Anesthesia Circuit Kit Flex EPA (Model MP17103), manufactured by Draeger, Inc., is being recalled due to the potential for cracks to form in the breathing circuit hose. This medical device accessory is designed to conduct medical gases between the anesthesia machine and patient during anesthetic procedures and is intended for single use only.

Approximately 13,620 units have been distributed nationwide in the United States and internationally to 24 countries, including Austria, Belgium, China, France, Germany, Japan, and the United Kingdom. The recall affects all lot numbers of Model MP17103.

This is an FDA Class I recall. Healthcare facilities should immediately identify all affected units by model and lot number and discontinue their use until they can be replaced with unaffected products.

The recalled product

Product: Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 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
Hazard: breathing-circuit-crack
Affected units: 13,620

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: MP17103
UDI Number 04048675695660
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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Same hazard · breathing circuit crack