SURGICOUNT 0622284120Recalls & reported problems
Stryker Corporation · + Gauze Sponge, 8 inch x 4 inch, 12 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 57613327512538), received between Jul 24, 2024 and Sep 4, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A ROBOTICS PROCEDURE, A 12PLY 8X4 SPONGE WAS PLACED INSIDE THE ABDOMEN THROUGH AN 8MM TROCAR. THE SPONGE WAS REMOVED, AND 15 MINUTES LATER, IT WAS DISCOVERED THAT THE RFID STRIP HAD FALLEN OFF AND WAS INSIDE THE PATIENT. THE RFID STRIP WAS REMOVED DURING THE PROCEDURE, BUT THE PATIENT WAS NOT CLOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140724 ↗MalfunctionJul 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818488 ↗MalfunctionJul 24, 2024Material Frayed; Material Frayed
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818483 ↗
Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices
- Vistec 7317Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 reports
- Situate G0804-12P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE120 reports
- Situate G0404-16P01CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE114 reports
- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
- Situate G0404-16P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE60 reports
- Arterial Line Kit 400115AArgon Medical Devices, Inc. · Gauze/Sponge, Internal, X-Ray Detectable1 recall0 reports
- AMD-RITMED 55992CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
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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