Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Product Name	Model Number	UDI-DI	Lot Numbers
Filter SafeStar 90 Plus	MP05785	04048675665762	All lot numbers
Filter SafeStar 55 Plus	MP05790	04048675558736	All lot numbers
Filter SafeStar 60A Plus	MP05795	04048675665786	All lot numbers
Filter/HME TwinStar HEPA Plus	MP05801	04048675665823	All lot numbers

What to Do

1. Do not use affected filters.
2. Remove unused stock from inventory.

On July 22, 2025, Draeger sent all affected customers an updated Urgent Medical Device Recall Notification recommending the following actions:

• Do not use any unused affected filters.
• Remove affected products from stock.
• Contact your Draeger Consumables Representative for information about alternative filters.
• Reach out to Draeger Customer Success (1-800-437-2437, press 2 then 1, or email US-Medical@draeger.com) to arrange product return and replacement. A Return Material Authorization and pre-paid shipping will be provided. 
• Ensure all potential users are aware of the recall and forward the notice to any third parties.
• Complete and return the updated Recall Return Response Acknowledgment and Receipt Form, even if previously completed.

Reason for Recall

Draeger is recalling these filters due to the risk of misleading capnography (carbon dioxide) readings, which could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations.

The use of affected filters may cause serious adverse health consequences, including airway injury, delayed or incorrect treatment, brain injury, and death.

There were serious injuries reported due to the slow increase of CO2 curve when using the sampling port of the filter. There have been no reports of death. 

Device Use

Draeger SafeStar and TwinStar filters are bidirectional breathing system filters used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination. They are typically used in hospitals during surgery or in intensive care units.

Contact Information

Customers in the U.S. with questions should contact Draeger Customer Success at 1-800-437-2437 (press 2, then 1) or US-Medical@draeger.com.

Additional FDA Resources (listed in order of most to least recent):

• FDA’s Enforcement Report 
• Medical Device Recall Database

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.