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Bard-Parker ® Carbon Rib-Back Blades 371115Recalls & 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
11
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840113201761), received between May 28, 2025 and Apr 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (6 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: 0 reportsApr 2024: 0 reportsMay 2024: 0 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: 3 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 3 reportsMar 2026: 2 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Unsealed Device Packaging6
  • Break4
  • Material Discolored1

Patient problems

  • No Clinical Signs, Symptoms or Conditions11

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 22, 2026Unsealed Device Packaging

    COMPLAINANT ALLEGES "FOUND SEVERAL 15 SURGICAL BLADES WHERE THE OUTER PACKAGING IS NOT SEALED PROPERLY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24957838 ↗
  • MalfunctionMar 26, 2026Break

    COMPLAINANT ALLEGES "BLADE BROKE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24705580 ↗
  • MalfunctionMar 26, 2026Unsealed Device Packaging

    COMPLAINANT ALLEGES "THE PACKAGING APPEARS TO BE IMPROPERLY FUSED, RESULTING IN A CRACK FORMING BENEATH THE BLADE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24698645 ↗
  • MalfunctionFeb 25, 2026Break

    COMPLAINANT ALLEGES "WE HAD THE TIP OF A #15 SCALPEL BLADE BREAK OFF INSIDE A PATIENT'S SHOULDER JOINT. THEY DID NOT FIND IT, FLUSHED THE PATIENT'S JOINT OUT VERY THOROUGHLY, AND TOOK AN X-RAY OF THE JOINT, WHICH REVEALED NOTHING RETAINED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24446157 ↗
  • MalfunctionFeb 24, 2026Break

    COMPLAINANT ALLEGES "FIRST BLADE BROKE. SECOND BLADE WAS DULL AND THEN BROKE AS WELL. NO PATIENT INJURY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24431480 ↗
  • MalfunctionFeb 4, 2026Break

    COMPLAINANT ALLEGES "DR. (B)(6) WAS IN THE MIDDLE OF ONE OF HIS ROUTINE WISDOM TEETH SURGERIES WHEN GOING TO USE THE 15 TO OPEN SITE # 1 THE 15 BROKE IN HALF, AS YOU CAN SEE IN THE PICTURE. NOBODY WAS HARMED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24261535 ↗
  • MalfunctionAug 20, 2025Material Discolored

    DISCOLORATION ON BLADES DURING PROCEDURE AND AFTER USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22850592 ↗
  • 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 22301607 ↗
  • MalfunctionJun 6, 2025Unsealed Device Packaging; Unsealed Device Packaging

    COMPLAINANT ALLEGES "NOT SEALED ON SIDE OF PACKAGING. THEREFORE, NOT STERILE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22161510 ↗
  • MalfunctionJun 3, 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 22136366 ↗
  • MalfunctionMay 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

    COMPLAINANT ALLEGES "SEAL ON STERILE PACKAGING IS COMPROMISED. DURING A PROCEDURE, IT WAS NOTICED THAT 15EA DID NOT HAVE A GOOD SEAL. NO DELAY IN PROCEDURE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22100336 ↗

Other BLADE, SCALPEL devices

All BLADE, SCALPEL devices →

Sources and updates

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