FDA Medical devices recall ·
Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1499-2025
- Date
- (initiated March 12, 2025)
- Company / brand
- Draeger, Inc.
3135 Quarry Rd, Telford, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 13620 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 intended for single use only
Why was it recalled?
The potential for cracks forming in the breathing circuit hose.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: MP17103; UDI Number 04048675695660; All lot numbers.
Distribution
Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1499-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.