AESCULAP BA823SURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046963840853), received between Mar 9, 2021 and Apr 27, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BA823SU - CARBON STEEL SAFETY SCALPEL #23. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRIMARY PACKAGING-TORN. THE PACKAGING OF THE SCALPEL (PRIMARY PACKAGING) TORE, CAUSING THE EQUIPMENT IS NOT STERILE. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731525 ↗
• MalfunctionMar 18, 2021Retraction Problem; Retraction Problem

  THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4) ((B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520064 ↗
• MalfunctionMar 18, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED TO AESCULAP AG THAT A CARBON STEEL SAFETY SCALPEL #23 (PART # BA823SU) FAILED DURING USE. ACCORDING TO THE COMPLAINANT, THE IO BLADE-FAILURE DURING USE. REPORTEDLY, THE PRIMARY PACKAGING OF THE SCALPEL TORE, CAUSING A LOSS OF STERILIZATION. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00184 ((B)(4) + BA823SU), 9610612-2021-00197 ((B)(4) + BA823SU), AND 9610612-2021-00183 ((B)(4) + BA823SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520062 ↗
• MalfunctionMar 18, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED TO AESCULAP AG THAT A CARBON STEEL SAFETY SCALPEL #23 (PART # BA823SU) FAILED DURING USE. ACCORDING TO THE COMPLAINANT, THE IO BLADE-FAILURE DURING USE. REPORTEDLY, THE PRIMARY PACKAGING OF THE SCALPEL TORE, CAUSING A LOSS OF STERILIZATION. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00184 ((B)(4) + BA823SU), AND 9610612-2021-00183 ((B)(4) + BA823SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520042 ↗
• MalfunctionMar 17, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BA823SU - CARBON STEEL SAFETY SCALPEL #23. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PACKAGING OF THE DEVICE WAS TORN. WHEN IT WAS OPENED, THE PACKAGING OF THE SCALPEL (PRIMARY PACKAGING) TORE, CAUSED UNSTERILE EQUIPMENT. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00172 ((B)(4) + BA823SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509480 ↗
• MalfunctionMar 17, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BA823SU - CARBON STEEL SAFETY SCALPEL #23. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PACKAGING OF THE DEVICE IS TORN. WHEN IT WAS OPENED, THE PACKAGING OF THE SCALPEL (PRIMARY PACKAGING) TORE, CAUSED UNSTERILE EQUIPMENT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00171 ((B)(4) + BA823SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509478 ↗
• MalfunctionMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BA823SU - CARBON STEEL SAFETY SCALPEL #23. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BLADE RETRACTS DURING INCISION. THE SCALPEL DOES NOT HOLD IN OPEN POSITION. THE PATIENT HARM IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445479 ↗