AESCULAP MD344Recalls & reported problems
Aesculap, Inc. · Disposable Filter, Reusable Filter · Class 2
Quick summary
This Aesculap MD344 filter is a disposable polypropylene filter used with sterilization wrap containers, trays and cassettes. The 28 reports mostly describe tiny pinholes appearing in the filters after sterilization, sometimes apparently marked by the container lid, along with filters arriving discolored or sliced. No deaths and no injuries were reported, and no recalls name this device. Reports mentioning the problem fell from 19 in the earlier 12-month period to 5 in the most recent one.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 14522281506819), received between May 8, 2023 and Aug 20, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (28 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/Hole28
- Device Contamination with Chemical or Other Material1
- Material Discolored1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Material Puncture/Hole
Dealer stated customer reported holes in filter after sterilization.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50359552 ↗MalfunctionJul 15, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25830688 ↗MalfunctionFeb 25, 2026Material Puncture/Hole
ACCORDING TO THE EVENT DESCRIPTION, THE FILTERS HAVE ONE PINPOINT HOLE IN MULTIPLE FILTERS WITHIN THE PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445919 ↗MalfunctionDec 3, 2025Material Puncture/Hole; Material Puncture/Hole
DEALER REPORTED THAT THE FILTERS KEEP COMING OUT WITH HOLES ON THEM. THE HOLES ARE FROM THE LID. THE LID SEEMS TO BE IMPRINTING ON THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707695 ↗MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE COMPLAINANT NURSING STAFF NOTICED/IDENTIFIED SMALL PIN HOLE DAMAGE IN ROUND FILTERS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496103 ↗MalfunctionNov 6, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE COMPLAINANT THE FILTER ARE COMING OUT OF STERILIZATION WITH HOLES ON THEM. REPORTEDLY THE HOLES ARE FROM THE LID THE LID SEEMS TO BE IMPRINTING ON THE FILTER. THE ISSUE IS RANDOMLY OCCURRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486021 ↗MalfunctionAug 18, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO AESCULAP INC. THAT THERE ARE HOLES IN THE ROUND FILTER POLYPROPYLENE (PART# MD344) POST STERILIZATION. ACCORDING TO THE COMPLAINANT THE FILTERS SPORADICALLY HAVE TONS OF LITTS HOLES AFTER STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22826369 ↗MalfunctionJun 23, 2025Material Puncture/Hole; Device Contamination with Chemical or Other Material; Material Puncture/Hole; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WERE PINHOLES IN THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306758 ↗MalfunctionJun 13, 2025Material Discolored; Material Puncture/Hole; Material Discolored; Material Puncture/Hole
ACCORDING TO THE COMPLAINANT 2 FILTERS AT TOP OF BOX/BAG ARE DISCOLORED AND SLICED. REST OF THE FILTERS ARE FINE AND USABLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205723 ↗MalfunctionJun 9, 2025Material Puncture/Hole; Material Puncture/Hole
SUPPLIER REPORTED THAT FILTERS WERE SHREDDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172001 ↗MalfunctionJun 2, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE EVENT DESCRIPTION: THE FILTERS WERE FOUND TO BE SHREDDED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22125452 ↗MalfunctionMay 29, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE EVENT DESCRIPTION: THE FILTERS ARRIVED WITH THE CENTER HOLE STILL IN TACT. THE HOLE IN THE MIDDLE WAS NOT PUNCHED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22104219 ↗MalfunctionMay 6, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE EVENT DESCRIPTION: THE FILTERS WERE FOUND TO BE SHREDDED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971731 ↗MalfunctionApr 24, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE EVENT DESCRIPTION: ON APRIL 08, 2025, THE FACILITY REPORTED VISIBLE HOLES IN THE FILTERS AFTER STEAM STERILIZATION IN A STERIS AMSCO 3053. STERILIZER HAD RECENTLY BEEN WORKED ON. AGE OF STERILIZER UNKNOWN BUT CUSTOMER ESTIMATES AROUND 20 YEARS. THE HOLES HAPPENED IN MULTIPLE LOADS, BUT NOT EVERY CONTAINER FILTER AFFECTED EACH TIME. WRAPPED TRAYS WERE FINE (PASSED, NO HOLES) IN AFFECTED LOADS. THE ISSUE HAPPENED TO VARIOUS LOT NUMBERS OF MD344 FILTERS. THE ISSUE HAPPENED IN THE SAME STERILIZER EACH TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903820 ↗MalfunctionApr 24, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE EVENT DESCRIPTION: ON APRIL 08, 2025, THE FACILITY REPORTED VISIBLE HOLES IN THE FILTERS AFTER STEAM STERILIZATION IN A STERIS AMSCO 3053. STERILIZER HAD RECENTLY BEEN WORKED ON. AGE OF STERILIZER UNKNOWN BUT CUSTOMER ESTIMATES AROUND 20 YEARS. THE HOLES HAPPENED IN MULTIPLE LOADS, BUT NOT EVERY CONTAINER FILTER AFFECTED EACH TIME WRAPPED TRAYS WERE FINE (PASSED, NO HOLES) IN AFFECTED LOADS. THE ISSUE HAPPENED TO VARIOUS LOT NUMBERS OF MD344 FILTERS. THE ISSUE HAPPENED IN THE SAME STERILIZER EACH TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903819 ↗MalfunctionMar 5, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE EVENT DESCRIPTION THE CUSTOMER FOUND A SMALL PIN HOLE IN THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21528175 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 8. IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART # MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114489 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 2. IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART # MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114482 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 4. IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART#: MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114132 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 7 IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART # MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113690 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 5: IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART # MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113684 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 3: IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART # MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113680 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 6 IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART # MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113679 ↗MalfunctionJan 9, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT 1: IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART # MD344) WAS USED DURING STERILIZATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THERE WERE HOLES PRESENT IN THE FILTER AFTER STERILIZATION. REPORTEDLY THERE WERE EIGHT (8) FILTERS REJECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113668 ↗MalfunctionNov 14, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTER POLYPROPYLENE (PART NUMBER MD344) WAS USED DURING AN OPERATING ROOM ASEPTIC PRESENTATION ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THE OPERATING ROOM REJECTED THE TRAY BECAUSE THERE WAS A RIP NEXT TOT, HE HOLE WHERE THE RETENTION PIN GOES IN. REPORTEDLY THE BACK TABLE WAS REJECTED DUE TO CONTAMINATION FROM THE FILTER. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20688971 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.