AESCULAP US994Recalls & reported problems
Aesculap, Inc. · ROUND FILTER W/O INDICATOR · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964930812), received between May 30, 2025 and Oct 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole3
- Device Contamination with Chemical or Other Material1
- Residue After Decontamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE COMPLAINANT SMALL PINHOLES WERE FOUND IN FILTERS THAT CAME FROM TWO SEPARATE PACKAGES OF US994 1000-PACK FILTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292960 ↗MalfunctionJun 17, 2025Material Puncture/Hole; Device Contamination with Chemical or Other Material; Material Puncture/Hole; Device Contamination with Chemical or Other Material
ACCORDING TO THE CUSTOMER: "WE HAVE SOME FILTERS WE ARE PULLING FROM THE BAG, INSPECTING UNDER THE LIGHT AND FINDING MICRO PIN HOLES. WE REMOVED THEM FROM SERVICE, GRABBED A NEW BAG AND HAVE SEVERAL MORE WE HAVE DISCOVERED. WE CANNOT PROVIDE THE LOT INFORMATION, AS THIS IS ON THE CARDBOARD BOX AND REMOVED PRIOR TO COMING INTO SPD, AS WE CANNOT HAVE CARDBOARD IN THE DEPARTMENT. WE HAD A TRAY REJECTED FROM THE OR TODAY FOR THE SAME MICRO PIN HOLE. THIS SEEMS TO BE A MANUFACTURE DEFECT ISSUE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237123 ↗MalfunctionMay 30, 2025Material Puncture/Hole; Residue After Decontamination; Material Puncture/Hole; Residue After Decontamination
AS REPORTED BY THE USER FACILITY: AS ADVISED, WE WILL INSPECT AND CONTINUE TO REJECT THE STERILIZATION FILTERS (US994) NOT ONLY FOR THE MICRO HOLES WE ARE FINDING BUT NOW FOR THE NEW IMPERFECTION, THE BLACK INK LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22118592 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.