Curad CUR47397RBRecalls & reported problems

Medline Industries, Inc. · PAD,NON-STICK,CURAD,3X4,10/BX,12BX/CS · Class 1

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00080196300085), received between Sep 10, 2026 and Sep 24, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Adhesive Too Strong” (3 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. 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

Adhesive Too Strong3
Infusion or Flow Problem1

Patient problems

Hemorrhage/Blood Loss/Bleeding2
Fluid Discharge1
Insufficient Information1
Pain1
Skin Tears1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 24, 2026Adhesive Too Strong
Patient problems: Insufficient Information
MAUDE report 50885570 ↗
MalfunctionSep 16, 2026Adhesive Too Strong
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50786014 ↗
MalfunctionSep 14, 2026Infusion or Flow Problem
Patient problems: Fluid Discharge
MAUDE report 50765213 ↗
MalfunctionSep 10, 2026Adhesive Too Strong
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Skin Tears
MAUDE report 50717585 ↗

Device details

UDI-DI	`00080196300085`
Brand	Curad
Model	CUR47397RB
Company	Medline Industries, Inc.
Product code	NAB · Gauze / sponge,nonresorbable for external use
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 2, 2023

Device type (GMDN): Wound-nonadherent dressing, absorbent, non-antimicrobial

A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

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All Gauze / sponge,nonresorbable for external use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.