SURGICOUNT 0622284160Recalls & reported problems

Stryker Corporation · + Gauze Sponge, 8 inch x 4 inch, 16 Ply, RFID, Double X-Ray · Class 1

All models of SURGICOUNT (20)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 57613327512552), received between Oct 23, 2023 and Jul 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Frayed2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionJul 29, 2025Material Frayed; Material Frayed
NO CHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647255 ↗
MalfunctionOct 23, 2023Material Frayed; Material Frayed
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17992792 ↗

Device details

UDI-DI	`57613327512552`
Brand	SURGICOUNT
Model	0622284160
Catalog no.	0622-284-160
Company	Stryker Corporation
Product code	GDY · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Nov 15, 2022

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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