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
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
- 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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