McKesson 168-35WRecalls & reported problems

Mckesson Medical-Surgical Inc. · Skin Staplers 35 Wide · 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 10612479226903), received between May 21, 2025 and May 21, 2025 — 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Entrapment of Device1

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.

MalfunctionMay 21, 2025Entrapment of Device; Entrapment of Device
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER BECAME STUCK ON TOP OF THE PATIENT'S HEAD. IT WAS FLAT AGAINST THE SKIN AND COULD NOT BE DISENGAGED. THE USER ATTEMPTED TO PRESS THE STAPLER AGAIN TO RELEASE IT, BUT IT REMAINED COMPLETELY STUCK. ANOTHER STAPLER WAS RETRIEVED AND USED TO PLACE ONE STAPLE IN THE HEAD, WHICH WAS COMPLETED WITHOUT ANY ISSUES.
Patient problems: Unspecified Tissue Injury
MAUDE report 22059531 ↗

Device details

UDI-DI	`10612479226903`
Brand	McKesson
Model	168-35W
Company	Mckesson Medical-Surgical Inc.
Product code	GDT · Staple, Removable (Skin)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 10, 2021

Device type (GMDN): Skin stapler/staple, non-bioabsorbable

A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

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Proximate PMW35
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Appose ULC 8886803712
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Appose ULC 8886803512
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Proximate PXW35
Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)
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Proximate PRW35
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All Staple, Removable (Skin) devices →

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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