AESCULAP BB515Recalls & reported problems
Aesculap AG · Scalpel Blades, Fig. 15, carbon steel, sterile, disposable, dispenser packaging, package of 100 pieces · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653019946), received between Jun 11, 2021 and Oct 15, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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
Device problems
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED TO AESCULAP AG THAT A CARBON STEEL SCALPEL BLADES #15 (PART # BB515) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT THE BLADE WAS LOSING THE CUTTING WIRE VERY FAST AND MORE EXCHANGES WERE REQUIRED DURING THE PROCEDURE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639822 ↗MalfunctionJun 11, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED TO AESCULAP AG THAT A CARBON STEEL SCALPEL BLADES #15 (PART # BB515) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, WHILE PERFORMING SURGERY ON HARD TISSUES, CAPSULE AND TENDON, THE PHYSICIAN NOTED THAT THE BLADE LOST THE CUTTING EDGE TOO FAST. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATION WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11987576 ↗
Other BLADE, SCALPEL devices
- Medline CISION15CSMedline Industries, Inc. · BLADE, SCALPEL1 recall2 reports
- Medline CISION15CSRMedline Industries, Inc. · BLADE, SCALPEL1 recall1 report
- Medline CISION10CSMedline Industries, Inc. · BLADE, SCALPEL1 recall1 report
- Medline CISION20CSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION21SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION12SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- SPSS Cartridges 73-8020Southmedic Incorporated · BLADE, SCALPEL1 recall0 reports
- Medline CISION11SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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