Kendall 131615Recalls & reported problems
Cardinal Health, Inc. · Scalpel #15 · Class 1
All models of Kendall (35)
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 10884527014491), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
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.
MalfunctionApr 13, 2022Break; Break
THE CUSTOMER REPORTED THAT THE BLADE WAS DETACHED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE BROKEN BLADE WAS DISCOVERED WHEN OPENED ON THE TRAY. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14105123 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page