AESCULAP JK440Recalls & reported problems
Aesculap AG · Bottom, without base perforation, Standard 1/1, outer length: 592 mm, outer width: 274 mm, outer heigth: 90 mm, inner length: 544 mm, inner width: 258 mm, inner heigth: 75 mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653130351), received between Sep 28, 2021 and Sep 28, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Residue After Decontamination” (1 report).
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.
Most reported problems
Device problems
- Residue After Decontamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2021Residue After Decontamination; Residue After Decontamination
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH JK440 - BOTTOM FOR 1/1 CONTAINER HEIGHT:90MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SILVER METALLIC AND BLACK PARTICLES WERE NOTICED AT THE BOTTOM OF THE INSTRUMENT TRAYS AFTER THE STEAM STERILIZATION CYCLE. AND IN THE CHAMBER OF THE UNITS. THERE WAS SIGNIFIANT SURGERY DELAY, BUT IT WAS FOUND IN STERILE PROCESSING BEFORE THE START OF THE OPERATION. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: JK489 - FULL-SIZE LID W/RETENTION PLATE SILVER - LOT UNKNOWN. JF949 - SILICONE CUSHIONING PAD 1/1 SIZE - LOT UNKNOWN. JM020 - EXTRA LONG MINI CONT.LID NON ANODIZED - LOT UNKNOWN. JM021 - EXTRA LONG MINI CONT.BOTTOM NON ANODIZED - LOT UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12542955 ↗
Other Wrap, sterilization devices
- Turbett Surgical TS1500Turbett Surgical Inc · Wrap, Sterilization2 recalls0 reports
- Turbett Surgical TS1000Turbett Surgical Inc · Wrap, Sterilization1 recall0 reports
- Turbett Surgical TS1200Turbett Surgical Inc · Wrap, Sterilization1 recall0 reports
- Halyard 34164O&M Halyard, Inc. · Wrap, sterilization11 reports
- Halyard 34145O&M Halyard, Inc. · Wrap, sterilization5 reports
- Halyard 34147O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34199O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34148O&M Halyard, Inc. · Wrap, sterilization3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.