Swann Morton Ltd. No. 11 BULK NON STERILE RETRACTABLE SCALPELSRecalls & reported problems
Swann-Morton Limited · A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device. · 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 05033955040918), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2022Mechanical Problem; Mechanical Problem
EMPLOYEE WASCLEANING THE BACK TABLE POST CASE. BLADE WAS RETRACTED. WHEN SHE PICK UP THE RETRACTED BLADE, THE BLADE POPPED FORWARD AND PUNCTURED HER PALM (PT HIV+).
Patient problems: Laceration(s)
MAUDE report 15438615 ↗
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
- 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
- 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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