SituateRecalls & reported problems across all models

We found 29 models of Situate by Covidien LP in the FDA's device registry (GUDID). Together they are named in 665 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2017 and Sep 29, 2026 — classified as 61 injuries, 604 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (220 reports).

3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Situate recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 21, 2024Open, 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 ↗

2. Nov 21, 2017Terminated

   Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.

   Z-1208-2018 · Root cause: Process control · Recall details · FDA record ↗

3. Oct 12, 2017Terminated

   This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.

   Z-1130-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Situate problems

Situate models

29 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Situate G0804-12P02CN-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  120 reports
• Situate G0404-16P01CN-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  114 reports
• Situate G0804-16P02CN-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  2 recalls1 report
• Situate 01-0031

  Counter, sponge, surgical
  97 reports
• Situate 01-0043

  Counter, sponge, surgical
  94 reports
• Situate L1818-04P01C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 recall20 reports
• Situate 01-0034

  Counter, sponge, surgical
  67 reports
• Situate G0404-16P01C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  60 reports
• Situate 01-0035

  Counter, sponge, surgical
  18 reports
• Situate G0804-12P02C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  14 reports
• Situate G0404-32P01C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  11 reports
• Situate 01-0046

  Counter, sponge, surgical
  10 reports
• Situate L1818-04P01CN-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  9 reports
• Situate G0404-32P01CN-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  7 reports
• Situate 01-0043R

  Counter, sponge, surgical
  5 reports
• Situate G0804-16P02C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  3 reports
• Situate L0418-04P01C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  2 reports
• Situate L1818-04P01C-R

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  2 reports
• Situate G0804-32P02C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate L0836-04P01C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate L1212-04P01C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate L1818-04P01C-L

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate TSD-0750C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate TSD-0875C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate TST-0750C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate VPK-0272C-R

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate 01-0034R

  Counter, sponge, surgical
  1 report
• Situate L0418-04P01CN-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report
• Situate TORG-0101C-1

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report

Recent Situate adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Frayed; Detachment of Device or Device Component

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

  MAUDE report 50938601 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE TONSIL SPONGE WAS PLACED IN A CAVITY AND THE STRING DETACHED FROM THE MIDDLE PORTION OF THE SPONGE, AND A PORTION FELL INTO THE PATIENT CAVITY. THE PIECE WAS FULLY RETRIEVED WHEN IT WAS FOUND AND REMOVED FROM THE PATIENT CAVITY PRIOR TO CLOSING. AN X-RAY WAS NOT REQUIRED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349903 ↗
• InjuryApr 7, 2026False Negative Result

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A RETAINED SPONGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24799922 ↗
• InjuryApr 6, 2026False Negative Result

  IT WAS REPORTED THAT THERE WAS A RETAINED SPONGE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24791106 ↗
• MalfunctionMar 10, 2026False Positive Result

  IT WAS REPORTED THAT DURING TESTING, THE CONSOLE WAS DETECTING WITH NOTHING REMAINING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555655 ↗
• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE GAUZE RF (RADIO FREQUENCY) TAG HAD DISLODGED. THE RF TAG HAD FELL INTO THE PATIENT'S CAVITY. IT WAS FULLY RETRIEVED AND X-RAY WAS NOT REQUIRED TO ASSIST IN LOCATING THE RF TAG. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415644 ↗
• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, TESTING, THE CUSTOMER DECIDED TO DO AN EXPERIMENT AND OPENED A PACK OF 10 CT RAYTECS AND MANIPULATED THE CHIP AT THE SEAM TO SEE WHAT WOULD HAPPEN. ON 2 OUT OF THE 10 RAYTECS THE CHIP POPPED OUT EASILY THROUGH THE SEAM WITH NO PRESSURE. ON THE OTHER RAYTECS THEY COULD NOT GET THE CHIP TO POP THROUGH THE SEAM EVEN WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414979 ↗
• MalfunctionDec 1, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE ACCESSORY DID NOT CONNECT TO THE CONSOLE AND WAS DETECTING LAPS EVEN THOUGH THE COUNT WAS CORRECT AND NO LAPS WERE RETAINED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679934 ↗
• MalfunctionNov 11, 2025False Positive Result; Connection Problem; False Positive Result; Connection Problem

  IT WAS REPORTED THAT ACCESSORY WOULD NOT CONNECT TO CONSOLE AND WAS DETECTING LAPS WHEN THE COUNT IS CORRECT AND THERE ARE NO LAPS RETAINED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520362 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083776 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083757 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083712 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083695 ↗
• 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 ↗
• MalfunctionAug 7, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING THE PREPARATION FOR USE; THE UNIT DETECTED A SPONGE THAT WAS NOT PRESENT. THE STAFF USED THE BACKUP AND VERIFIED THAT THERE WAS NO SPONGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745913 ↗

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