Swann Morton Ltd. No. 15 STAINLESS STERILE BLADESRecalls & reported problems
Swann-Morton Limited · Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05033955003050), received between Jun 13, 2024 and May 1, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
- Insufficient Device Problem Information2
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.
MalfunctionMay 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY, "DURING A ENT PROCEDURE A NO. 15 BLADE BROKE WHILE BEING USED ON A PATIENT" IT ALSO STATED THAT, "THE BLADE IN QUESTION WAS DISCARDED AFTER THE PROCEDURE, NO PERSON HAD BEEN ADVERSELY AFFECTED BY THE ISSUE AND NO FURTHER MEDICAL/SURGICAL INTERVENTION HAD BEEN REQUIRED. THE PROCEDURE WAS DELAYED DUE TO THIS ISSUE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941050 ↗MalfunctionJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY, "BLADE SHREDDED DURING PROCEDURE". IT WAS STATED THAT, "NO SERIOUS INJURY WAS REPORTED AT THIS TIME".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19526888 ↗
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.
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