Hemospray recallZ-1979-2023 · Wilson-Cook Medical Inc. · initiated May 22, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Wilson-Cook Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm notified their consignees by letter and email beginning on 05/22/2023. The notice explained the issue, risk, and requested the following: Complete and return the Acknowledgement Form, ensure the notification is shared with appropriate personnel, down to the user level or customers if devices were further distributed, report any adverse events.

Recall details

Recall number: Z-1979-2023
Status: Open, Classified
Initiated by the company: May 22, 2023
Posted by the FDA: Jun 21, 2023
Recalling firm: Wilson-Cook Medical Inc.
Quantity: 14,877 units
Product code: QAU
FDA submissions: K200972
Distribution: US Nationwide - Worldwide Distribution

Product description

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

Code information (models, lots, serial numbers)

UDI/DI : a) 00827002210493, b) 00827002213463; All unexpired lot numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Hemospray G21049
Cook Incorporated · Hemostatic device for endoscopic gastrointestinal use
3 recalls1 death83 reports

Product lines

HemosprayCook Incorporated · 2 models · 535 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 92345).

Z-1978-2023 · Open, Classified
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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