Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog...
FDA Device Recall #Z-1498-2025 — Class I — March 12, 2025
Recall Summary
| Recall Number | Z-1498-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | March 12, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Draeger, Inc. |
| Location | Telford, PA |
| Product Type | Devices |
| Quantity | 9250 units |
Product Description
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
Reason for Recall
The potential for cracks forming in the breathing circuit hose.
Distribution Pattern
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
Lot / Code Information
Model/Catalog Number: MP02752; UDI Number 04048675389729; All lot numbers.
Other Recalls from Draeger, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0933-2026 | Class I | Draeger Vapor 2000. Unheated, calibrated anesth... | Nov 24, 2025 |
| Z-0934-2026 | Class I | Draeger Vapor 3000. Unheated, calibrated anesth... | Nov 24, 2025 |
| Z-0590-2026 | Class I | ErgoStar CM 40 Model/Catalog Number: MP01840 ... | Nov 10, 2025 |
| Z-0591-2026 | Class I | ErgoStar CM 45, Model/Catalog Number: MP01845... | Nov 10, 2025 |
| Z-0593-2026 | Class I | ErgoStar CM 60, Model/Catalog Number: MP01860... | Nov 10, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.