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Filter/HME TwinStar HEPA Plus MP05801Recalls & reported problems

Drägerwerk AG & Co. KGaA · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K221836); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 16, 2025Open, Classified

    Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

    Z-2160-2025 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221836. One submission often covers many models, so check the product and lot details in each record.

  • Z-2158-2025 · Jun 16, 2025 · Open, Classified
    SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
  • Z-2159-2025 · Jun 16, 2025 · Open, Classified
    SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
  • Z-2161-2025 · Jun 16, 2025 · Open, Classified
    SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Other Filter, Bacterial, Breathing-Circuit devices

All Filter, Bacterial, Breathing-Circuit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.