Breathing system filters are recalled

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The FDA has announced a recall for certain bidirectional breathing system filters because there is a risk of misleading capnography readings. Medical supply company Draeger is removing the SafeStar and TwinStar filters from the market. These filters may be used in veterinary facilities, according to the FDA’s Center for Veterinary Medicine.¹ 

Draeger SafeStar and TwinStar filters used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination, according to the company. They are typically used in hospitals during surgery or in intensive care units.²

Misleading readings for carbon dioxide (CO₂)based on incorrect waveform interpretations could lead to treatments that are unnecessary or harmful to patients. Injuriesto the airway, or brain, as well as death may occur. The FDA identified the recall as serious, citing the risk of significant injury or death with continued use. Serious injuries have been reported because of the slow increase of the CO₂ curve when the sampling port of the filter is used. No deaths have been reported.^1,2

The recalled filters are as follows²:

1. Filter SafeStar 90 Plus: Model MP05785, UDI-DI 04048675665762, all lot numbers
2. Filter SafeStar 55 Plus: Model MP05790, UDI-DI 04048675558736, all lot numbers
3. Filter SafeStar 60A Plus: Model MP05795, UDI-DI 04048675665786, all lot numbers
4. Filter/HME TwinStar HEPA Plus: Model MP05801, UDI-DI 04048675665823, all lot numbers

These filters should not be used, according to the FDA and Draeger, and unused stock should be removed from a hospital’s inventory. Additionally, a letter sent by Draeger on July 22, 2025, to customers affected by the recall recommended further actions as follows²:

• 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.

US customers with questions should contact Draeger Customer Success at 1-800-437-2437 (press 2, then 1) or US-Medical@draeger.com for additional support.

References

1. Breathing system filters recall: Draeger removes SafeStar and TwinStar filers due to risk of misleading carbon dioxide (CO₂) readings. News release. FDA. August 13, 2025. Accessed August 14, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3edbdec
2. Medical device recalls. FDA. August 12, 2025. Accessed August 14, 2025. https://www.fda.gov/medical-devices/medical-device-recalls/breathing-system-filters-recall-draeger-removes-safestar-and-twinstar-filters-due-risk-misleading?utm_medium=email&utm_source=govdelivery