CLASS II Device recall · Reported 25 Sep 2019 · FDA Enforcement Report

Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical

Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat, distributed nationwide in the US. The recall was initiated on 24 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224

Quantity recalled160 units

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-2541-2019
FDA event ID: 83395
Recalling firm: Wilson-Cook Medical, Winston Salem, NC
Classification: Class II
Status: Terminated
Recall initiated: 24 Jul 2019
FDA classified: 13 Sep 2019
Reported: 25 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

24 Jul 2019	Recall initiated by company
13 Sep 2019	Classified by FDA	+51 days
25 Sep 2019	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

Potential for Hemospray device to be unable to spray powder due to misassembly of devices.

Product as listed by the FDA

Hemospray Endoscopic Hemostat

Where it was distributed

Nationwide distribution to CA, CO, CT, FL, IL, IN, KY, LA, MN, MO, NC, NJ, NY, OH, PA, RI, SD, TX, VA, WA. International distribution to Canada, Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain, and United Kingdom.

Nationwide California Colorado Connecticut Florida Illinois Indiana Kentucky Louisiana Minnesota Missouri North Carolina New Jersey New York Ohio Pennsylvania Rhode Island South Dakota Texas Virginia Washington

Questions about this recall

Why was it recalled?

Potential for Hemospray device to be unable to spray powder due to misassembly of devices.

Which lots are affected?

Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224

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.

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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