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Bard-Parker ® Stainless Steel Blades 371215Recalls & 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

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

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840113204380), received between Jun 30, 2021 and Mar 18, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1
  • Material Discolored1
  • Structural Problem1
  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 18, 2026Unsealed Device Packaging

    COMPLAINANT ALLEGES "THE PACKAGING IS NO LONGER SEALED. IT HAS SEPARATED EXPOSING THE BLADE. IT SEEMS TO BE ALL THE BLADES FROM THIS LOT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24631002 ↗
  • InjuryJan 14, 2026Break

    COMPLAINANT ALLEGES "WHEN THE SURGEON WAS MAKING AN INCISION IN THE CONCHA BULLOSE THE 15 BLADE BROKE IN HALF AND FELL DOWN INTO THE SINUS CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE BLADE WITH THE SCOPE AND SUCTION AND BOTH PIECES WERE COMPARED TO ENSURE THE ENTIRE BLADE WAS REMOVED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24070962 ↗
  • MalfunctionJun 30, 2021Material Discolored; Structural Problem

    BLADE PACKAGE WAS OPENED DURING PRE-SURGICAL SET UP WHEN SCRUB TECH NOTICED RAGGED CUTTING EDGE AND DISCOLORATION OF BLADE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12094392 ↗

Other BLADE, SCALPEL devices

All BLADE, SCALPEL devices →

Sources and updates

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