CLASS II ONGOING Device recall · Reported 28 Jun 2023 · FDA Enforcement Report

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) Hemo recalled

Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat: Reference Part Numbers: a) Hemo-7, distributed nationwide in the US. The recall was initiated on 22 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI : a) 00827002565722, b) 00827002246638; All unexpired lot numbers

Quantity recalled63,830 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-1978-2023
FDA event ID: 92345
Recalling firm: Wilson-Cook Medical, Winston Salem, NC
Classification: Class II
Status: Ongoing
Recall initiated: 22 May 2023
FDA classified: 21 Jun 2023
Reported: 28 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

22 May 2023	Recall initiated by company
21 Jun 2023	Classified by FDA	+30 days
28 Jun 2023	Published in enforcement report	+7 days

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

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide - Worldwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI : a) 00827002565722, b) 00827002246638; All unexpired lot numbers

Where was it sold?

US Nationwide - Worldwide Distribution

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 92345

This product is part of a recall event; the main page for the event is Hemospray Endoscopic Hemostat: Reference Part Numbers: a) Hemo recalled.

Reported	Class	Recall	Company	Reason	Where
28 Jun 2023	CLASS II	Hemospray Endoscopic Hemostat: Reference Part Numbers: a) Hemo recalled	Wilson-Cook Medical	Other	Nationwide

More recalls from Wilson-Cook Medical

All 24

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
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

Other Surgical Instruments recalls

All 3,816

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide