Situate L1818-04P01C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521700956), received between Jul 11, 2018 and Aug 26, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 21, 2024Class IIOpen, Classified

   Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.

   Z-1330-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SPONGE HAD LOOSE STRINGS AND FRAYED EDGES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892511 ↗
• InjurySep 11, 2024False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP REPLACEMENT PROCEDURE, THE SPONGE WAS NOT DETECTED BUT IT WAS PRESENT. WHILE CLOSING THE INCISION THE SURGICAL COUNT WAS INCORRECT, THEY WERE MISSING A RAYTEC SPONGE. THE NEXT STEP IS TO INFORM THE SURGEON ABOUT THE MISSING RAYTEC AND USE THE RFID TO WAND THE INCISION. A STERILE DRAPE WAS PLACED OVER THE WAND AND THE RFID WAS USED TO WAND OVER THE INCISION ON THE HIP. THE DEVICE DID NOT DETECT E SPONGE INCISE THE HIP. THEY THEN USED THE RFID ON THE TRASH AND THE RFID DID NOT DETECT THE MISSING RAYTEC. THEN THE WAND WAS USED OVER THE NINE RAYTEC SPONGES THAT NOT MISSING. THE RFID DID DETECT THE RAYTECS. THE TEAM WAS REASSURED THAT THE RFID WAS WORKING. THE TEAM THEN TRIED AGAIN TO USE THE RFID OVER THE SURGICAL SITE AND IT DID NOT DETECT THE RAYTEC. THE SURGEON THEN ENTERED THE ROOM AND INSTRUCTED THE PHYSICIAN ASSISTANT TO OPEN THE SURGICAL SITE WOUND BACK UP TO CHECK FOR THE RAYTEC. ONCE THE WOUND WAS OPENED THE RAYTEC SPONGE WAS LOCATED INSIDE THE PATIENT'S HIP. AFTER THE RAYTEC WAS REMOVED AND THE COUNTS WERE NOW COMPLETE THEY USED THE RFID TO WAND OVER THE SPONGE THAT WAS INSIDE THE PATIENT, THE RFID STILL DID NOT DETECT THE SPONGE.

  Patient problems: Insufficient Information

  MAUDE report 20195898 ↗
• MalfunctionApr 19, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  ACCORDING TO THE REPORTER, PRIOR TO USE, CUSTOMER DISCOVERED A NON-RFID SPONGES IN RFID LAP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142379 ↗
• MalfunctionApr 19, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD INCORRECT/WRONG ITEMS IN PACKAGE. PHOTOS WERE ATTACHED SHOWING A DIFFERENT COLOR OF RADIO FREQUENCY TAG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142315 ↗
• MalfunctionApr 17, 2024Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE STAFF OPENED THE PACKAGE, THE RFID SPONGES WERE MISSING CHIPS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128847 ↗
• MalfunctionApr 17, 2024Component Missing; Device Misassembled During Manufacturing /Shipping; Component Missing; Device Misassembled During Manufacturing /Shipping

  ACCORDING TO THE REPORTER, PRIOR TO USE, ONE OF THE NURSES WAS OPENING A CASE AND NOTICED THE STRINGS OF THE LAP THAT WAS OPENED WERE BLUE, INSTEAD OF GREEN, WHEN THE SCRUB TECH CHECKED, IT WAS MISSING THE RF TAGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126010 ↗
• MalfunctionJun 29, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING CAESAREAN SECTION, THE DEVICE WAS LINTING. OBSTETRIC (OB) PHYSICIANS WERE SEEING PARTICLES COME OFF THE SPONGES WHILE BEING USED. DESCRIBED THE PARTICLES AS DUST. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231819 ↗
• MalfunctionDec 29, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS LINTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074737 ↗
• MalfunctionAug 4, 2021Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE SPONGE WAS FALLING APART NEAR THE X-RAY DETECTABLE TAG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273759 ↗
• MalfunctionApr 30, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LAP SPONGES ARE SHREDDING. THIS WAS A SAFETY ISSUE FOR THE PATIENTS WHICH WAS HAPPENED SEVERAL TIMES. SHREDDING WAS NOTICED WHEN LAP SPONGE WAS PLACE INSIDE PATIENT, PHYSICIAN NOTICED. ATTACHED PHOTO SHOWED THAT THE SPONGE HAD SOME STRINGS DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752037 ↗
• MalfunctionApr 30, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LAP SPONGES ARE SHREDDING. THIS WAS A SAFETY ISSUE FOR THE PATIENTS WHICH WAS HAPPENED SEVERAL TIMES. SHREDDING WAS NOTICED WHEN LAP SPONGE WAS PLACE INSIDE PATIENT, PHYSICIAN NOTICED. ATTACHED PHOTO SHOWED THAT THE SPONGE HAD SOME STRINGS DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752026 ↗
• MalfunctionApr 30, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LAP SPONGES ARE SHREDDING. THIS WAS A SAFETY ISSUE FOR THE PATIENTS WHICH WAS HAPPENED SEVERAL TIMES. SHREDDING WAS NOTICED WHEN LAP SPONGE WAS PLACE INSIDE PATIENT, PHYSICIAN NOTICED. ATTACHED PHOTO SHOWED THAT THE SPONGE HAD SOME STRINGS DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752016 ↗
• MalfunctionApr 30, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LAP SPONGES ARE SHREDDING. THIS WAS A SAFETY ISSUE FOR THE PATIENTS WHICH WAS HAPPENED SEVERAL TIMES. SHREDDING WAS NOTICED WHEN LAP SPONGE WAS PLACE INSIDE PATIENT, PHYSICIAN NOTICED. ATTACHED PHOTO SHOWED THAT THE SPONGE HAD SOME STRINGS DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752008 ↗
• MalfunctionApr 30, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LAP SPONGES ARE SHREDDING. THIS WAS A SAFETY ISSUE FOR THE PATIENTS WHICH WAS HAPPENED SEVERAL TIMES. SHREDDING WAS NOTICED WHEN LAP SPONGE WAS PLACE INSIDE PATIENT, PHYSICIAN NOTICED. ATTACHED PHOTO SHOWED THAT THE SPONGE HAD SOME STRINGS DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751993 ↗
• InjuryMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RIGHT BREAST WIRE LOCALIZED LUMPECTOMY WITH RIGHT SENTINEL NODE BIOPSY AND LUMICELL PROBE, WHERE PATIENT'S CLEAR IMAGING WAS TAKEN OF THE BREAST FOR CANCER SCREENING, THE LINTING OF THE SPONGE THEN APPEARED IN THE BREAST POCKET UPON VISUALIZATION OF THE IMAGING SCANS. SURGEON CREATED A POCKET IN THE BREAST TO INSERT AN IMAGING PROBE BUT PRIOR TO INSERTION OF PROBE, THE PHYSICIAN INSERTED A LAPAROTOMY SPONGE TO ABSORB ADDITION FLUIDS IN THE POCKET. X-RAY WAS REQUIRED TO ASSIST IN LOCATION ALL THE LINT AND MOST WERE REMOVED. PHOTOGRAPH WAS RECEIVED AND SHOWED SEVERAL LONG STRINGS LEFT IN THE PATIENT'S CAVITY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11454384 ↗
• MalfunctionOct 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE MADE IN CHINA TAG FELL OFF FROM THE SPONGE INTO THE PATIENT AND WAS RETRIEVED. X-RAY WAS NOT REQUIRED TO ASSIST IN LOCATING THE PIECES, ALL COUNTS WERE CORRECT PRIOR TO CLOSING AND ALL OTHER TOWELS HAD THE TAG INTACT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10745784 ↗
• MalfunctionDec 2, 2019Material Frayed; Material Frayed

  ACCORDING TO THE REPORTER, THE GAUZE WAS FALLING APART AND FLAKING.

  Patient problems: No Patient Involvement

  MAUDE report 9397055 ↗
• MalfunctionOct 9, 2019Material Fragmentation; Device Contaminated During Manufacture or Shipping; Material Fragmentation; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE REPORTER, DURING SET-UP ONTO THE STERILE FIELD, THE STAFF MEMBER NOTICED WHAT LOOKED LIKE OR LINT INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9171954 ↗
• MalfunctionJul 26, 2018Material Fragmentation; Material Frayed; Device Fell; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE SURGICAL PROCEDURE, THE SURGEON NOTICED EDGES OF THE LAP SPONGE BECAME FRAYED, THE FRAYED FIBERS FELL INTO THE PATIENT'S SURGICAL INCISION WHILE STILL OPEN, THE SURGEON WAS ABLE TO RETRIEVE ALL THE FRAYED FIBERS WITHIN THE INCISION. THERE WAS NO PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7724544 ↗
• MalfunctionJul 11, 2018Material Frayed; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SURGICAL PROCEDURE, THE SURGEON NOTICED THE EDGES OF THE SPONGE BECAME FRAYED. THE FRAYED FIBERS FELL INTO THE PATIENT'S SURGICAL INCISION AND WAS ABLE TO RETRIEVE ALL THE FRAYED FIBERS WITHIN THE INCISION. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678585 ↗