Kendall 139093Recalls & reported problems
Cardinal Health, Inc. · Scalpel #15 · Class 1
All models of Kendall (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884527014521), received between Nov 16, 2021 and Oct 27, 2022 — classified as 1 injury, 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 16, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE BLADE BREAKS FROM THE HANDLE OF THE SCALPEL EASILY. THE ENTIRE BLADE IS DETACHING FROM THE HANDLE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15678757 ↗InjuryNov 16, 2021Break; Break
THE CUSTOMER REPORTED THAT DURING THE SURGICAL PROCEDURE, THE BLADE FROM THE SCALPEL BROKE IN HALF INSIDE THE PATIENT'S KNEE. A LARGER INCISION NEEDED TO BE MADE TO REMOVE THE BROKEN PIECE. THE BROKEN BLADE WAS REMOVED IN ONE PIECE AND PER PROTOCOL, AN XRAY WAS TAKEN TO VERIFY THERE WAS NO PRODUCT LEFT BEHIND. THERE WAS NO HARM TO THE PATIENT OR STAFF DUE TO THIS BROKEN SCALPEL BLADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12824820 ↗
Other SCALPEL, ONE-PIECE devices
- AESCULAP BA823SUAesculap AG · SCALPEL, ONE-PIECE7 reports
- NA 232110Medos International Sàrl · SCALPEL, ONE-PIECE5 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
- Kendall 139090Cardinal Health, Inc. · SCALPEL, ONE-PIECE1 report
- DeRoyal D4511NS-500Deroyal Industries, Inc. · SCALPEL, ONE-PIECE1 report
- Bard-Parker ® Safety Scalped 372615Aspen Surgical Products, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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