CARDINAL HEALTH 23250-407Recalls & reported problems
Cardinal Health 200, LLC · Cardinal Health Lap Sponge 4 X 18 in. Prewashed X Ray Detectable Softpack · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30885380121702), received between Jun 5, 2025 and Jun 18, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Adverse Event Without Identified Device or Use Problem1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT POST-OPERATIVELY, A LAPAROTOMY SPONGE WAS RETAINED IN THE PATIENT FOLLOWING A SURGICAL PROCEDURE, NECESSITATING A SECOND SURGERY TO RETRIEVE THE SPONGE. THE RETAINED SPONGE RESULTED IN EXTENDED PATIENT'S HOSPITALIZATION BY 3-4 DAYS. AN X-RAY WAS TAKEN TO ASSIST IN LOCATING THE RETAINED SPONGE. PATIENT WAS INITIALLY TAKEN TO INTENSIVE CARE UNIT BUT HAD TO RETURN DUE TO COMPLICATIONS. THE SPONGE WAS FULLY RETRIEVED DURING THE SECOND SURGERY. IT WAS NOTED THAT THE SPONGE COUNT WAS CORRECT, AND MACHINE READ A CORRECT COUNT AT THE END OF THE INITIAL PROCEDURE BUT DID NOT DETECT A SPONGE WAS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22286608 ↗InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST-OPERATIVELY, A LAPAROTOMY SPONGE WAS RETAINED IN THE PATIENT FOLLOWING A SURGICAL PROCEDURE, NECESSITATING A SECOND SURGERY TO RETRIEVE THE SPONGE. THE RETAINED SPONGE RESULTED IN EXTENDED PATIENT'S HOSPITALIZATION BY 3-4 DAYS. AN X-RAY WAS TAKEN TO ASSIST IN LOCATING THE RETAINED SPONGE. PATIENT WAS INITIALLY TAKEN TO INTENSIVE CARE UNIT BUT HAD TO RETURN DUE TO COMPLICATIONS. THE SPONGE WAS FULLY RETRIEVED DURING THE SECOND SURGERY. IT WAS NOTED THAT THE SPONGE COUNT WAS CORRECT, AND MACHINE READ A CORRECT COUNT AT THE END OF THE INITIAL PROCEDURE BUT DID NOT DETECT A SPONGE WAS IN THE PATIENT. EVENT DATE AND INITIAL REPORTER WERE UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 22154585 ↗
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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