CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

Hemo-7 Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical

Wilson-Cook Medical is recalling Hemo-7 Hemospray Endoscopic Hemostat, distributed nationwide in the US. The recall was initiated on 4 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lot numbers manufactured 01/16/2017 - 01/15/2020 of both the following: HEMO-7 Order Number G56572 HEMO-10 Order Number G21049

Quantity recalled89,423 devices total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1745-2020
FDA event ID: 84822
Recalling firm: Wilson-Cook Medical, Winston Salem, NC
Classification: Class II
Status: Terminated
Recall initiated: 4 Feb 2020
FDA classified: 17 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

4 Feb 2020	Recall initiated by company
17 Apr 2020	Classified by FDA	+73 days
29 Apr 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HEMO-7 Hemospray Endoscopic Hemostat

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lot numbers manufactured 01/16/2017 - 01/15/2020 of both the following: HEMO-7 Order Number G56572 HEMO-10 Order Number G21049

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84822

Reported	Class	Recall	Company	Reason	Where
29 Apr 2020	CLASS II	Hemo-10 Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide

More recalls from Wilson-Cook Medical

All 23

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Device	CLASS II	Instinct Plus Endoscopic Clipping Device recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Teslatome Bipolar Sphincterotomes recalled by Wilson-Cook Medical	Wilson-Cook Medical	Other	4 states
11 Feb 2026Device	CLASS II	Nasal Jejunal Feeding Tube recalled by Wilson-Cook Medical	Wilson-Cook Medical	Packaging Defects	NC
11 Dec 2024Device	CLASS II	Cook Medical Hemo-7-EU Hemospray Endoscopic Hemostat recalled	Wilson-Cook Medical	Device Malfunction	NC
23 Oct 2024Device	CLASS II	Cook Medical Hemo-7 Hemospray Endoscopic Hemostat recalled	Wilson-Cook Medical	Other	Nationwide

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