Z-1746-2020Class II

HEMO-10 Hemospray Endoscopic Hemostat

Name: Z-1746-2020 HEMO-10 Hemospray Endoscopic Hemostat
Creator: Wilson-Cook Medical Inc.
Published: 2020-02-04
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2020-02-04 / Terminated / root cause: design

FDA source

Wilson-Cook Medical Inc. began a recall of HEMO-10 Hemospray Endoscopic Hemostat on 2020-02-04. FDA classified it as Class II and gives the reason as "Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1746-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-04
Posted: 2020-04-17
Terminated: 2021-01-15
Recalling firm: Wilson-Cook Medical Inc.
Product: HEMO-10 Hemospray Endoscopic Hemostat
Product code: QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Reason for recall: Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
Root cause tag: design
FDA root cause: Device Design
Action: Cook Medical notified customers initially via "URGENT: MEDICAL DEVICE RECALL" letters sent on about 02/04/2020 and 02/25/2020. The letters contained the same information and informed customers that Cook Medical has received complaints that the handle and/or activation knob on Hemospray Endoscopic Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Instructions to customers included to examine inventory for affected devices, cease use of them and quarantine them, return affected devices immediately to Cook Medical, and complete and return the Acknowledgement and Receipt Form. Additionally customers were instructed to inform appropriate personnel and customers, if further distributed, of the recall down to the user level. Questions or concerns can be directed to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in commerce: 89,423 devices total
Distribution: Nationwide distribution. International distribution to Bahrain, Belarus, Canary Islands, Gibraltar, Guadeloupe, Guernsey, Iraq, Israel, Jersey, Jordan, Kuwait, Lebanon, Martinique, Monaco, Morocco, Oman, Pakistan, Qatar, Reunion, Saudi Arabia, Tunisia, United Arab Emirates, Unites States, Canada, Netherlands Antilles, Chile, Egypt, Japan, Mexico, Peru, Puerto Rico, Trinidad and Tobago, Australia, Brunei Dassalarum, Hong Kong, Korea, Myanmar, Macau, Malaysia, New Zealand, Philippines, Singapore, Thailand, Vietnam, Argentina, Brazil, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Iceland, Italy, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia
Product codes and lots: All Lot numbers manufactured 01/16/2017 - 01/15/2020 of both the following: HEMO-7 Order Number G56572 HEMO-10 Order Number G21049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1746-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1745-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1746-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-17

Product code QAU

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)