Z-1978-2023Class II

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663

Name: Z-1978-2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663
Creator: Wilson-Cook Medical Inc.
Published: 2023-05-22
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2023-05-22 / Open, Classified

FDA source

Wilson-Cook Medical Inc. began a recall of Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663 on 2023-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1978-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-22
Posted: 2023-06-21
Recalling firm: Wilson-Cook Medical Inc.
Product: Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Product code: QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 63,830 units
Distribution: US Nationwide - Worldwide Distribution
Product codes and lots: UDI/DI : a) 00827002565722, b) 00827002246638; All unexpired lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1978-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1978-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21
Z-1979-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21

Product code QAU

K200972Class IIHemospray Endoscopic HemostatWilson-Cook Medical, Inc. / cleared 2020-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)