Bard-Parker ® Stainless Steel Blades 371210Recalls & 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
- 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 00840113204182), received between Aug 12, 2025 and Nov 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
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.
MalfunctionNov 25, 2025Break; Break
COMPLAINANT ALLEGES "THE TWO SURGICAL BLADES INCLUDED IN THE PACK BROKE DURING SURGERY AND THIS HAPPENED 6 TIMES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23649574 ↗MalfunctionAug 12, 2025Break; Break
COMPLAINANT ALLEGES "BARD-PARKER BLADE BROKE WHILE IN USE. BOTH PIECES WERE RETRIEVED AND VERIFIED BY (B)(6), RN AND MD THAT ALL PIECES WERE ACCOUNTED FOR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22789230 ↗
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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