The Recall Desk
SevereFDA (Devices)·Z-2160-2025·Announced 2025-08-06

HME TwinStar HEPA Plus Filters Recalled for CO2 Measurement Defect

HME TwinStar HEPA Plus Filters, made by Draeger, are recalled due to reports of slow CO2 curve increases when gas samples are taken from the filter's sampling port.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall, which requires a minimum severity score of 4. The defect affects CO2 measurement accuracy in a respiratory monitoring device. No illnesses or deaths are reported in the source material.

Plain-English summary

Draeger, Inc. is recalling the HME TwinStar HEPA Plus Filter, a bidirectionally breathing system filter. Approximately 1,019,782 units with Model No. MP05801 are included in this recall, distributed worldwide and across all U.S. states.

Reports indicate that CO2 curve readings increase slowly when gas samples are taken from the gas sampling port of the filters. This measurement defect could affect the accuracy of CO2 monitoring through these sampling ports.

The FDA has classified this as a Class I recall, indicating a serious potential health risk. The recall affects all lot numbers of the affected model.

The recalled product

Product
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Manufacturer
Draeger, Inc.
Category
Medical Device — Breathing System Filter
Hazard
  • co2-measurement-defect
  • sampling-port-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No. MP05801
  • UDI: 04048675665823
  • All Lots.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category