Situate G0404-16P01CN-1Recalls & reported problems
Covidien LP · Gauze-RF and X-ray Detectable USP Type VII, 16 Ply. Caution: For Manufacturing, Processing or Repacking. · Class 1
All models of Situate (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Situate X-ray detectable gauze is a surgical sponge with a radiopaque strip used during operations. Most of the 114 reports describe the gauze breaking into fragments, fraying, or leaving loose strings, and a few describe a thread left inside a patient. The reports include 3 injuries and no deaths, and 17 note no consequences to the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 114
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10884521700611), received between Jul 23, 2018 and Jul 7, 2025 — classified as 3 injuries, 111 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (92 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 Fragmentation92
- Detachment of Device or Device Component31
- Material Frayed8
- Contamination2
- Insufficient Device Problem Information1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Consequences Or Impact To Patient17
- Insufficient Information11
- Foreign Body In Patient8
- Device Embedded In Tissue or Plaque6
- No Information6
- No Patient Involvement6
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2025Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE, THE GAUZE WAS FRAYING BUT BASED ON THE PHOTO RECEIVED, THE GAUZE STRINGS WERE DETACHED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412105 ↗MalfunctionJun 5, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PRIOR TO LAMINECTOMY PROCEDURE, THE RADIOPAQUE STRIP WAS DETACHED FROM COTTON PATTY. A NEW SINGLE STERILE WAS USED OFF SHELF TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150173 ↗MalfunctionJun 5, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO USE ON LAMINECTOMY PROCEDURE, THE SPONGES WERE FALLING APART WHEREIN STRIPS DETACHING FROM THE COTTON PATTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22149897 ↗MalfunctionMar 31, 2025Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER PRIOR TO USE, THE GAUZE HAD LINT DEBRIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730023 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS LEAVING STRINGS BEHIND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127814 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS LEAVING STRINGS BEHIND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127792 ↗MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS LEAVING STRINGS BEHIND. A THREAD WAS IN THE PATIENT'S BELLY AND HAD TO GET OUT. NO ADDITIONAL INTERVENTION WAS REQUIRED. THEY QUICKLY ASSESSED THE INCIDENT SINCE IT WAS CAUGHT AS SOON AS IT HAPPENED. THERE WAS NO PATIENT INJURY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20081499 ↗MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS LEAVING STRINGS BEHIND. A THREAD WAS IN THE PATIENT'S BELLY AND HAD TO GET OUT. NO ADDITIONAL INTERVENTION WAS REQUIRED. THEY QUICKLY ASSESSED THE INCIDENT SINCE IT WAS CAUGHT AS SOON AS IT HAPPENED. THERE WAS NO PATIENT INJURY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20081400 ↗MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE DEVICE WAS LEAVING STRINGS BEHIND. A THREAD WAS IN THE PATIENT'S BELLY AND HAD TO GET OUT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 20051157 ↗MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE DEVICE WAS LEAVING STRINGS BEHIND. A THREAD WAS IN THE PATIENT'S BELLY AND HAD TO GET OUT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 20045709 ↗MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE DEVICE WAS LEAVING STRINGS BEHIND. A THREAD WAS IN THE PATIENT'S BELLY AND HAD TO GET OUT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 20044342 ↗MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE DEVICE WAS LEAVING STRINGS BEHIND. A THREAD WAS IN THE PATIENT'S BELLY AND HAD TO GET OUT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 20043943 ↗MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE DEVICE WAS LEAVING STRINGS BEHIND. A THREAD WAS IN THE PATIENT'S BELLY AND HAD TO GET OUT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 20043630 ↗MalfunctionApr 18, 2024Contamination; Material Fragmentation; Contamination; Material Fragmentation
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, THERE WAS A PDS SURGICAL PACK WITH UNKNOWN LINT IN 4X4 RFID SPONGES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19135303 ↗MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE RADIO FREQUENCY IDENTIFICATION (RFID) TAG DETACHED FROM GAUZE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18994267 ↗MalfunctionFeb 21, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAMPLES RECEIVED WAS LINTING X-RAY GAUZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18753963 ↗MalfunctionFeb 21, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAMPLES RECEIVED WAS LINTING X-RAY GAUZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18751603 ↗MalfunctionFeb 14, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE LARGE PIECES OF WHITE LINT ON THE DEVICE WHICH APPEARED THAT THE LINT AS FROM THE DEVICE THEMSELVES AND NOT FROM ANYTHING ELSE INSIDE THE PACK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18705900 ↗MalfunctionJan 16, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, THE RAYTECS INCLUDED IN THE CURRENT MINOR PACKS HAVE BEEN SHEDDING LINT AND FALLING APART.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18519038 ↗MalfunctionJan 16, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRIOR TO USE, THE RAYTECS INCLUDED IN THE CURRENT MINOR PACKS HAVE BEEN SHEDDING LINT AND FALLING APART. THE SURGEON RETRIEVED PIECES FROM THE OR FIELD, AND RECREATED WITH TWO OTHER SPONGES - SHOOK IT AND PIECES OF VARIOUS SIZES (COTTON) WERE FALLING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18519028 ↗MalfunctionJan 1, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRIOR TO USE, THE GAUZE WAS FALLING APART. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423120 ↗MalfunctionJan 1, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING SURGERY, THE GAUZE HAD LINT ISSUES FROM THE RAYTECS IN THE BASIC PACKS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423116 ↗MalfunctionDec 29, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING SURGERY, THE GAUZE HAD LINT ISSUES FROM THE RAYTECS IN THE BASIC PACKS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419736 ↗MalfunctionDec 29, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING SURGERY, THE GAUZE HAD LINT ISSUES FROM THE RAYTECS IN THE BASIC PACKS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419725 ↗MalfunctionDec 19, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SPONGE IN THE BASIC PACKS WERE DROPPING LINT AND WERE MUCH THINNER THAN NORMAL. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18358829 ↗
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 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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