Z-0774-2019Class II

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

Name: Z-0774-2019 COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
Creator: Wilson-Cook Medical Inc.
Published: 2018-12-18
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2018-12-18 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc. began a recall of COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S on 2018-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0774-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Posted: 2019-01-25
Terminated: 2020-12-14
Recalling firm: Wilson-Cook Medical Inc.
Product: COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
Product code: FFF Cover, Biopsy Forceps
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).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall by letter in Europe on 18-December-2018 and 20-December-2018. The notices were sent in Japan today, 21-December-2018. The letter requested recall to the user level and return of the affected product.
Quantity in commerce: 8 units
Distribution: France, Ireland, Japan
Product codes and lots: Lot Number W4035256

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0774-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0774-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-25
Z-0775-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-25

Product code FFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)