Severity
Critical
FDA Devices recall · Reported April 9, 2025
The potential for cracks forming in the breathing circuit hose.
Draeger, Inc. recalled Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model… — a critical-severity action.
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model… was recalled by Draeger, Inc. in April 9, 2025. Reason: The potential for cracks forming in the breathing circuit hose.. Check the official notice for the remedy. Verify recall #Z-1498-2025 with the FDA Devices before acting.
The recall
Draeger, Inc. issued this critical-severity FDA Devices recall — The potential for cracks forming in the breathing circuit hose..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1498-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1498-2025) was formally reported on April 9, 2025, with the manufacturer initiating the action on March 12, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Draeger, Inc. is listed as the recalling firm, operating out of Telford, PA. Federal records list the affected scope as 9250 units.
The documented reason for this recall is: The potential for cracks forming in the breathing circuit hose. Distribution data in the federal record shows the product reached: Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Phili…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category — 40,409 medical devices recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
9250 units
Related Recalls
6
6 from same agency
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
The potential for cracks forming in the breathing circuit hose.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1498-2025 |
| Date reported | April 9, 2025 |
| Date initiated | March 12, 2025 |
| Recalling firm | Draeger, Inc. |
| Firm location | Telford, PA |
| Affected scope | 9250 units |
| 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, Si… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
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This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 9, 2025.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.