Bard-Parker ® Disposable Scalpels 371615Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840113202652), received between Jan 29, 2025 and Jan 29, 2025 — classified as 1 injury.
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
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2025Break; Break
COMPLAINANT ALLEGES "WRITER WAS PERFORMING A LEFT 1ST TOE AMPUTATION AND WAS ATTEMPTING TO DISARTICULATE THE TOE AT THE METATARSAL HEAD JOINT SPACE WHEN THE SCALPEL BLADE SNAPPED AND BROKE OFF, IN WOUND BED. WRITER HAD SCALPEL BLADE SNAP AND STOPPED THE PROCEDURE AND CONTACTED (PRIMARY SUPERVISOR) AND MADE AWARE, WHO CAME TO PATIENT BEDSIDE IN CLINIC TO ASSESS AND ATTEMPT TO RECOVER SCALPEL BLADE. PHYSICIAN CONTINUED TO REMOVED TOE AND WAS UNABLE TO FIND THE REMAINING SCALPEL BLADE IN THE WOUND BED. TOE AMPUTATION SITE WAS DRESSED WITH A STERILE DRESSING AND XRAY OF LEFT FOOT WAS DONE WHICH REVEALED THE REMAINING SNAPPED SCALPEL BLADE JUST DISTAL TO THE LEFT 1ST METATARSAL BONE. A SUBSEQUENT PROCEDURE WAS NEEDED TO REMOVE THE RETAINED PORTION OF THE BLADE."
Patient problems: Foreign Body In Patient
MAUDE report 21268691 ↗
Other SCALPEL, ONE-PIECE devices
- AESCULAP BA823SUAesculap AG · SCALPEL, ONE-PIECE7 reports
- 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 372615Aspen 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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