Medline MDS71757Recalls & reported problems
Medline Industries, Inc. · SPONGE,DISSECTOR,ROUND CHERRY,XR,ST,5/PK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884389106294), received between Jun 29, 2017 and Jun 29, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Disassembly” (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.
Most reported problems
Device problems
- Disassembly1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY "THE PRODUCT WAS LOOSE AND FRAYING LEAVING LOOSE PARTICLES THEY HAD TO RETRIEVE DURING USE".
Patient problems: Foreign Body In Patient
MAUDE report 17225229 ↗MalfunctionJun 29, 2017Disassembly
DURING AN ANTERIOR CERVICAL DISCECTOMY C4-C5 AND C5-C6, PHYSICIAN WAS USING THE MEDLINE CHERRY DISSECTOR SPONGES AND ACCORDING TO THE PHYSICIAN, WERE "FALLING APART" DURING THE DISSECTION. THE PHYSICIAN'S CONCERN IS TWO-FOLD. ONE, HE DID NOT WANT ANY FRAGMENTS FROM THE SPONGE LEFT IN THE SPINAL CANAL AND SECONDLY, SINCE THE CHERRY SPONGES NEEDED TO BE EXCHANGED MORE OFTEN, THE PROCEDURE AND ANESTHESIA TIME COULD BE LONGER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6683895 ↗
Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices
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- 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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