McKesson 168-35Recalls & reported problems
Mckesson Medical-Surgical Inc. · Skin Staplers 35 REGULAR · Class 1
Data updated Oct 16, 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 10612479226880), received between Feb 3, 2026 and Feb 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
- Unintended Ejection1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Entrapment of Device; Unintended Ejection
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SKIN STAPLER FIRED TWO STAPLES AT ONCE AND WOULD NOT DETACH FROM THE STAPLE GUN. THE STAPLE WAS STUCK TO PATIENT'S SCALP FOR PERIOD OF TIME BEFORE BEING ABLE TO BE REMOVED AND BEGAN THE PROCEDURE AGAIN.
Patient problems: Unspecified Tissue Injury
MAUDE report 24243260 ↗
Other Staple, Removable (Skin) devices
- WECK IPN028492Teleflex Incorporated · STAPLE, REMOVABLE (SKIN)1,377 reports
- WECK IPN008818Teleflex Incorporated · STAPLE, REMOVABLE (SKIN)711 reports
- WECK IPN028493Teleflex Incorporated · STAPLE, REMOVABLE (SKIN)564 reports
- Proximate PMW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)131 reports
- Appose ULC 8886803712Covidien LP · STAPLE, REMOVABLE (SKIN)68 reports
- Appose ULC 8886803512Covidien LP · STAPLE, REMOVABLE (SKIN)66 reports
- Proximate PXW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)37 reports
- Proximate PRW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)20 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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