MEDLINE INDUSTRIES, INC. MDS251536LFRecalls & reported problems

Medline Industries, Inc. · SPONGE,LAP,8"X36",XRAY,ST,5/PK,40PK/CS · Class 1

Data updated Oct 18, 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 10080196743902), received between Jun 3, 2021 and Jun 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Protective Measures 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

Protective Measures Problem1

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.

MalfunctionJun 3, 2021Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE X-RAY DETECTABLE (XRD) LAP SPONGE WAS FOUND TO NOT BE XRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11929606 ↗

Device details

UDI-DI	`10080196743902`
Brand	MEDLINE INDUSTRIES, INC.
Model	MDS251536LF
Company	Medline Industries, Inc.
Product code	GDY · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Class	Class 1
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	May 14, 2025

Device type (GMDN): Radiopaque woven surgical sponge

A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

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All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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