The Recall Desk
ModerateFDA (Devices)·Z-0774-2019·Announced 2019-02-06

Wilson-Cook Medical Recalls Mislabelled Captura Serrated Biopsy Forceps

Wilson-Cook Medical is recalling 8 units of Captura Serrated Biopsy Forceps in France, Ireland, and Japan due to mislabeling.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Wilson-Cook Medical Inc. is recalling 8 units of COOK MEDICAL Captura Serrated Biopsy Forceps with Spike (model DBF-2.4SN-230SP-20-S). The affected units are identified by Lot Number W4035256 and were distributed in France, Ireland, and Japan.

The recall was initiated because the Captura Serrated Forceps with Spike were mislabeled as Captura Serrated Large Forcep-No Spike (model DBF-2.4SL-230-20-S). Additionally, the Captura Serrated Large Forcep-No Spike units were mislabeled as Captura Serrated Forceps with Spike. This labeling error could lead to the use of the wrong instrument during medical procedures.

Healthcare facilities and distributors in the affected regions should stop using the recalled products and contact Wilson-Cook Medical for further instructions.

The recalled product

Product
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
Affected units
8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number W4035256

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →