HemosprayRecalls & reported problems across all models

We found 2 models of Hemospray by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 535 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2018 and Sep 30, 2026 — classified as 2 deaths, 64 injuries, 469 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (334 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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

Hemospray 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. Aug 20, 2026Open, Classified

   Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

   Z-3177-2026 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

2. Aug 29, 2024Open, Classified

   Specific lots of product have been manufactured with nonconforming raw materials.

   Z-0036-2025 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

3. May 22, 2023Open, Classified

   There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

   Z-1979-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. May 22, 2023Open, Classified

   There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

   Z-1978-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Hemospray problems

Hemospray models

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

• Hemospray G56572

  Hemostatic device for endoscopic gastrointestinal use
  3 recalls1 death452 reports
• Hemospray G21049

  Hemostatic device for endoscopic gastrointestinal use
  3 recalls1 death83 reports

Recent Hemospray adverse event reports

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

• MalfunctionSep 30, 2026Activation Failure

  During an unknown endoscopic procedure, the physician used a Cook Hemospray Endoscopic Hemostat.It was reported that they had a problem with the release of Hemospray powder. They managed to make a first release of dust "[spray]" but then had no more CO2 "[carbon dioxide]".At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted. Additional attempts to gather this information will be made.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948580 ↗
• MalfunctionSep 30, 2026Activation Failure

  During an unknown endoscopic procedure, the physician used a Cook Hemospray Endoscopic Hemostat. It was reported that they had a problem with the release of Hemospray powder. Once the red ring nut was screwed on, they heard the CO2 cylinder vent without the possibility of releasing dust.At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted. Additional attempts to gather this information will be made.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947588 ↗
• InjurySep 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941349 ↗
• InjurySep 29, 2026Obstruction of Flow; Activation Failure

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 50941288 ↗
• MalfunctionSep 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936728 ↗
• MalfunctionSep 29, 2026Failure to Disconnect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936676 ↗
• MalfunctionSep 21, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843097 ↗
• MalfunctionSep 21, 2026Activation Failure

  During an endoscopic hemostasis procedure in the stomach, the physician used a Cook Hemospray Endoscopic Hemostat.It was reported that the powder was not coming out. The tool "[catheter]" was already in the patient "[unable to spray - subject of report]".A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841968 ↗
• MalfunctionSep 16, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793091 ↗
• MalfunctionSep 15, 2026Complete Blockage; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779987 ↗
• MalfunctionSep 15, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779557 ↗
• MalfunctionSep 11, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736869 ↗
• MalfunctionSep 8, 2026Activation Failure

  During an endoscopic hemostasis procedure, the physician used three (3) Cook Hemospray Endoscopic Hemostats. It was reported that the three (3) devices all had the same issue of not dispensing the powder as if it was clogged. They changed catheters and had the same issue.At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672544 ↗
• MalfunctionSep 8, 2026Activation Failure

  During an endoscopic hemostasis procedure, the physician used a Cook Hemospray Endoscopic Hemostat. It was reported that "[the device]" did not deploy "[Unable to spray powder]".At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670219 ↗
• MalfunctionAug 19, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50313375 ↗

Other Cook Incorporated products

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