FDA Medical devices recall ·
Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1496-2025
- 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
- 780 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 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 Component: Not applicable
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: MP02738; UDI Number 04048675389637; 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-1496-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.