McKesson 16-6004-BRecalls & reported problems

Mckesson Medical-Surgical Inc. · OR TOWEL · Class 2

Data updated Oct 13, 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 20612479174690), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Fragmentation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED BY THE CUSTOMER THAT SMALL PARTICLES ARE COMING OFF THE TOWELS DURING SURGERY. IT WAS COMMUNICATED THAT THIS HAS OCCURRED OVER THE PAST COUPLE OF MONTHS RESULTING IN THE DOCTOR AND ASSISTANTS HAVING TO PICK THE SMALL PARTICLES OUT OF WOUNDS. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20027545 ↗

Device details

UDI-DI	`20612479174690`
Brand	McKesson
Model	16-6004-B
Company	Mckesson Medical-Surgical Inc.
Product code	KKX · Drape, Surgical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 21, 2023

Device type (GMDN): Patient surgical drape, single-use

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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