CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report

Cook Medical Hemo-7-EU Hemospray Endoscopic Hemostat recalled

Wilson-Cook Medical is recalling Cook Medical Hemo-7-EU Hemospray Endoscopic Hemostat. The recall was initiated on 31 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.

Quantity recalled46 devices

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-0582-2025
FDA event ID: 95755
Recalling firm: Wilson-Cook Medical, Winston Salem, NC
Classification: Class II
Status: Ongoing
Recall initiated: 31 Oct 2024
FDA classified: 2 Dec 2024
Reported: 11 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

31 Oct 2024	Recall initiated by company
2 Dec 2024	Classified by FDA	+32 days
11 Dec 2024	Published in enforcement report	+9 days

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

Reason for recall

Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.

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

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

Where it was distributed

Distribution was OUS only to Argentina, Brazil, and Israel.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.

Where was it sold?

Distribution was OUS only to Argentina, Brazil, and Israel.

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
23 Oct 2024Device	CLASS II	Cook Medical Hemo-7 Hemospray Endoscopic Hemostat recalled	Wilson-Cook Medical	Other	Nationwide
13 Dec 2023Device	CLASS II	Quantum Ttc Biliary Balloon Dilator recalled by Wilson-Cook Medical	Wilson-Cook Medical	Other	NC

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