PremierPro X8435Recalls & reported problems

Prestige Ameritech, Ltd. · PremierPro Lap Sponge 18"x18" Sterile, 5/pk · Class 1

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818566010582), received between Jun 17, 2021 and Mar 19, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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

Contamination1

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 19, 2026
THE PACK OF LAPS WAS NOTED TO BE MISSING THE BLUE LOOPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639326 ↗
MalfunctionJun 17, 2021Contamination
CIRCULATOR PASSED SCRUB TECH A PACK OF LAP SPONGES USING STERILE TECHNIQUE. WHEN SCRUB STARTED TO COUNT THE LAPS, SHE NOTICED A HAIR BETWEEN TWO OF THEM. TECH HANDED THE LAPS BACK TO CIRCULATOR AND REMOVED HER OUTER GLOVES. TECH DONNED NEW OUTER GLOVES. PACKAGING AND LAPS SAVED.
Patient problems: Insufficient Information
MAUDE report 12016404 ↗

Device details

UDI-DI	`00818566010582`
Brand	PremierPro
Model	X8435
Company	Prestige Ameritech, Ltd.
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	Mar 23, 2026

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