Filter SafeStar 55 Plus MP05790Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048675558736), received between Mar 12, 2025 and May 26, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Decreased Sensitivity” (1 report).

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-2159-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2025Imprecision; Decreased Sensitivity; Imprecision; Decreased Sensitivity

  IT WAS REPORTED THAT THE ETCO2-CURVE WAS DISPLAYED FLATTENED. DURING FURTHER INTERNAL REVIEW, IT WAS FOUND THAT THE EVENT WAS TO BE ASSESSED REPORTABLE BECAUSE THE CHANGED CURVE COULD LEAD TO MISINTERPRETATION BY THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084501 ↗
• InjuryMar 12, 2025Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE FOLLOWING WAS REPORTED ¿SUDDEN EMERGENCY SITUATION: CLINICAL SITUATION APPEARED AS A MASSIVE BRONCHOSPASM DUE TO AN ANAPHYLACTIC REACTION TO THE ANTIBIOTIC CEFUROXIME, WITH VENTILATION PRESSURES OF 40 MBAR ONLY A VT OF 20 - 120 ML, LATER PARTLY UP TO 220 ML COULD BE ACHIEVED, THERE WAS AN IMMEDIATE VITAL THREAT!!! CORRECT TUBE POSITION (LARYNGOSCOPIC AND BROCHOSCOPIC POSITION CHECK, EXCLUSION OF A CUFF HERNIA, NO INDICATION OF ASPIRATION, MEDICATION WAS GIVEN ACCORDING TO THE GUIDELINES, AFTER SWITCHING TO THE EVITA 4 INTENSIVE CARE VENTILATOR (NEW PATIENT FILTER!) THE PATIENT COULD BE VENTILATED IMMEDIATELY WITH NORMAL PRESSURES, THE CHECK OF THE ANESTHESIA MACHINE REVEALED NO DEFECTS, BUT THE ANESTHESIA FILTER USED (VISUALLY UNREMARKABLE) IS ONLY PASSABLE FOR AIR AT HIGH PRESSURE.¿ ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE OPERATION WAS CANCELED DUE TO THE SYMPTOMS DESCRIBED ABOVE.

  Patient problems: Bronchospasm

  MAUDE report 21580868 ↗

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-2160-2025 · Jun 16, 2025 · Open, Classified
  HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
• Z-2161-2025 · Jun 16, 2025 · Open, Classified
  SafeStar 60A Plus Filter. Bidirectionally breathing system filter.