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Bard-Parker ® Carbon Rib-Back Blades 371110Recalls & reported problems

Aspen Surgical Products, Inc. · Intended for tissue separation, and other procedures that require a sharp surgical blade to puncture or cut. · Class 1

All models of Bard-Parker Carbon Rib-Back Blades (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840113201525), received between Mar 18, 2024 and Dec 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 2 reportsJul 2025: 2 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break3
  • Unsealed Device Packaging3
  • Dull, Blunt1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • Insufficient Information1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 22, 2025Break; Break

    COMPLAINT ALLEGES, "BLADE BROKE DURING USE. NO PATIENT HARM HAS BEEN REPORTED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23872589 ↗
  • MalfunctionAug 12, 2025Dull, Blunt; Dull, Blunt

    COMPLAINANT ALLEGES, "THREE BLADES THAT WERE REPORTEDLY DULL UPON USE.".

    Patient problems: Insufficient Information

    MAUDE report 22786251 ↗
  • MalfunctionJul 28, 2025Break; Break

    COMPLAINANT ALLEGES "WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING BLADE BROKE DURING A PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22636122 ↗
  • MalfunctionJul 25, 2025Unsealed Device Packaging; Unsealed Device Packaging

    COMPLAINANT ALLEGES, "THE CUSTOMER HAS REPORTED THAT THE PACKAGE WAS NOT SEALED AND THE PRODUCT WAS NOT STERILE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22613438 ↗
  • MalfunctionJun 20, 2025Unsealed Device Packaging; Unsealed Device Packaging

    COMPLAINANT ALLEGES "THE PACKAGE IS NOT SEALED COMPLETELY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22301466 ↗
  • MalfunctionJun 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

    COMPLAINANT ALLEGES "THE PACKAGE IS NOT COMPLETELY SEALED. 1 EACH WAS FOUND DURING SET UP FOR A PROCEDURE, NO DELAY OCCURRED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22122478 ↗
  • MalfunctionMay 13, 2025Break; Break

    COMPLAINANT ALLEGES: "BLADE BROKE IN HALF AS SURGEON WAS CUTTING PATIENT, THIS IS A MAJOR SAFETY CONCERN AND SHOULD BE REPORTED TO THE MANUFACTURER ASPEN. THE SURGEON WAS CUTTING INTO THE PATIENT'S SOFT TISSUE. NO SIGNIFICANT DELAY IN PROCEDURE, AND NO INJURY TO PATIENT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22014455 ↗
  • MalfunctionMay 20, 2024

    #10 BLADE WITH RUSTING 10 MINUTES AFTER EXPOSED TO NORMAL SALINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19355353 ↗
  • MalfunctionMar 18, 2024

    RUSTED AFTER OPENING BLADE PACKET ON STERILE FIELD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18920725 ↗

Other BLADE, SCALPEL devices

All BLADE, SCALPEL devices →

Sources and updates

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