Bard-Parker ® Safety Scalped 372615Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840113203642), received between May 14, 2026 and May 14, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Unsealed Device Packaging
COMPLAINANT ALLEGES "TODAY WE RECEIVED A BOX OF 372615 THAT IS DAMAGED. EACH BLADE HAS A STICKY SPOT WITH A HOLE IN THE PACKAGE AND SOME ARE NOT SEALED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173307 ↗
Other SCALPEL, ONE-PIECE devices
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- NA 232110Medos International Sàrl · SCALPEL, ONE-PIECE5 reports
- Kendall 139093Cardinal Health, Inc. · SCALPEL, ONE-PIECE2 reports
- Integra® Miltex® 33-100Integra Lifesciences Production Corporation · SCALPEL, ONE-PIECE2 reports
- Swann Morton Ltd. No. 11 BULK NON STERILE RETRACTABLE SCALPELSSwann-Morton Limited · Scalpel, One-Piece1 report
- DeRoyal D4511NS-500Deroyal Industries, Inc. · SCALPEL, ONE-PIECE1 report
- Kendall 139090Cardinal Health, Inc. · SCALPEL, ONE-PIECE1 report
- Bard-Parker ® Safety Scalped 372621Aspen Surgical Products, Inc. · SCALPEL, ONE-PIECE1 report
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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