SURGICOUNT 0631018180Recalls & reported problems
Stryker Corporation · + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray · Class 1
All models of SURGICOUNT (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 37613327512800), received between Oct 25, 2022 and Jul 29, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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. 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
- Material Frayed3
- Delivered as Unsterile Product1
- Device Contaminated During Manufacture or Shipping1
- False Positive Result1
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Material Frayed; Material Frayed
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648147 ↗MalfunctionJul 29, 2025Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DEVICE CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647009 ↗MalfunctionOct 1, 2024False Positive Result; Illegible Information; False Positive Result; Illegible Information
PER THE ACCOUNT, A SPONGE WAS NOT ABLE TO BE SCANNED FROM A WOUND PACK PROCEDURE, WHICH COULD HAVE RESULTED IN A SPONGE BEING RETAINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343193 ↗MalfunctionJan 22, 2024Material Frayed; Material Frayed
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556464 ↗MalfunctionOct 25, 2022Material Frayed; Material Frayed
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15666585 ↗
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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