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
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page