CLASS II Device recall · Reported 6 Feb 2019 · FDA Enforcement Report

Cook Medical Captura Serrated Biopsy Forceps With Spike recalled

Wilson-Cook Medical is recalling Cook Medical Captura Serrated Biopsy Forceps With Spike, with Spike, Dbf-2.4SN-230SP-20-S. The recall was initiated on 18 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number W4035256

Quantity recalled8 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-0774-2019
FDA event ID: 81875
Recalling firm: Wilson-Cook Medical, Winston Salem, NC
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2018
FDA classified: 25 Jan 2019
Reported: 6 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

18 Dec 2018	Recall initiated by company
25 Jan 2019	Classified by FDA	+38 days
6 Feb 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

The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).

Product as listed by the FDA

COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

Where it was distributed

France, Ireland, Japan

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number W4035256

Where was it sold?

France, Ireland, Japan

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 81875

Reported	Class	Recall	Company	Reason	Where
6 Feb 2019	CLASS II	Cook Medical Captura Serrated Large Forcep-no Spike recalled	Wilson-Cook Medical	Labeling Errors	NC

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