MEDLINE NON21430LFRecalls & reported problems
Medline Industries, Inc. · GAUZE,SPONGE,4"X4",16PLY,XRAY,STRL,LF · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10080196832347), received between May 3, 2019 and Sep 28, 2026 — classified as 5 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed5
- Material Fragmentation4
- Material Integrity Problem4
- Difficult to Open or Remove Packaging Material1
- Material Split, Cut or Torn1
- Product Quality Problem1
Patient problems
- Foreign Body In Patient6
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926668 ↗OtherSep 25, 2026Difficult to Open or Remove Packaging Material
It was reported that ¿This sponge opened weird. Couldn¿t use because it was not sterile.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897177 ↗MalfunctionSep 23, 2026Material Frayed
It was reported that they have been receiving packs of NON21430LF Gauze Sponges in the same Lot Number 6052208044 and case and the ends are frayed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867126 ↗MalfunctionSep 22, 2026Material Frayed
It was reported that the Raytec was easily fraying.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858281 ↗MalfunctionMay 15, 2026Material Fragmentation
CUSTOMER STATES RAYTEC FALLING APART.
Patient problems: Insufficient Information
MAUDE report 25193564 ↗MalfunctionMay 13, 2026Material Frayed
CUSTOMER CONTACT REPORTED THAT DURING USE, THE SPONGE BEGAN TO FRAY, WITH THREADS DETACHING FROM THE SPONGE.
Patient problems: Insufficient Information
MAUDE report 25165315 ↗MalfunctionMar 19, 2026Material Integrity Problem
ACCORDING TO THE CUSTOMER, THE "RAYTEC 4X4 SPONGES ARE COMING APART AND FRAGMENTS ARE STAYING IN THE PATIENT".
Patient problems: Foreign Body In Patient
MAUDE report 24639628 ↗InjuryMar 19, 2024Material Frayed; Material Frayed
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 DURING A "TOTAL PARATHYROIDECTOMY" WHEN USING THE PRODUCT "STRANDS OF MATERIAL WERE LEFT BEHIND IN THE PATIENT CAVITY".
Patient problems: Foreign Body In Patient
MAUDE report 18935185 ↗MalfunctionFeb 13, 2024
ON (B)(6) 2024 AT APPROXIMATELY 1300 DURING A UNI KNEE A RAYTEC BECAME STUCK IN THE PATIENTS KNEE UNDER AN INSTRUMENT. WHEN THE SURGEON PULLED IT OUT IT SHREDDED INTO TWO PIECES. ALL PIECES WERE RECOVERED. NO X-RAYS NEEDED, ALL COUNTS WERE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18704223 ↗MalfunctionOct 20, 2023
ELDERLY MALE WITH HISTORY OF SEVERE SPINAL STENOSIS. PROCEDURE: LUMBAR INSTRUMENTATION FUSION 4+ LEVELS, INTERSEGMENTAL DECOMPRESSION LUMBAR 2-LUMBAR 3, LUMBAR 3-LUMBAR 4, LUMBAR 4-LUMBAR 5, LUMBAR 5-SACRAL 1. WHEN SETTING UP FOR SURGERY, THE MEDLINE X-RAY DETECTABLE GAUZE SPONGES WERE REMOVED FROM PACKAGING AND HAD FOREIGN SUBSTANCE ATTACHED. NOT USED OR PUT ONTO SURGICAL FIELD. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR GAUZE / SPONGE, NONRESORBABLE FOR EXTERNAL USE, MEDLINE (PER SITE REPORTER). UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17975038 ↗InjuryOct 5, 2023Material Integrity Problem; Material Integrity Problem
PER THE FACILITY THE GAUZE SPONGE "FRAYED IN THE PATIENT".
Patient problems: Foreign Body In Patient
MAUDE report 17877061 ↗InjuryJul 13, 2023Material Integrity Problem; Material Integrity Problem
InjuryJan 31, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY "THE RAYTECS ARE UNRAVELING STRINGS INSIDE THE PATIENT".
Patient problems: Foreign Body In Patient
MAUDE report 16274748 ↗InjuryAug 17, 2020Material Frayed
IT WAS REPORTED THAT THE GAUZE WAS NOTED TO BE FRAYING IN THE SPINE DURING THE PROCEDURE AND REQUIRED MANUAL REMOVAL DURING THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 10415214 ↗MalfunctionMay 14, 2019Material Fragmentation; Product Quality Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT THE 4X4-GAUZE SPONGES "HAD POOR INTEGRITY" RESULTING IN LOOSE THREADS AND/OR GAUZE SPLITTING IN THE SURGICAL SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8608070 ↗MalfunctionMay 3, 2019Material Fragmentation
IT WAS REPORTED THAT THE GAUZE SPONGE LEFT LOOSE THREADS IN THE SURGICAL SITE AND IRRIGATION AND FORCEPS WERE USED TO SUCCESSFULLY RETRIEVE THESE THREADS FROM THE SURGICAL SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8577856 ↗
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
- AMD-RITMED 85995CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
- Medical Action Industries 403Medical Action Industries 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page