FDA Medical devices recall ·

Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-1498-2025
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
9250 units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 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: MP02752; UDI Number 04048675389729; 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-1498-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.