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
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
- Medline CISION15CSMedline Industries, Inc. · BLADE, SCALPEL1 recall2 reports
- Medline CISION10CSMedline Industries, Inc. · BLADE, SCALPEL1 recall1 report
- Medline CISION15CSRMedline Industries, Inc. · BLADE, SCALPEL1 recall1 report
- Medline CISION12SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION10CSRMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION21CSMedline 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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