Wilson-Cook Medical Recalls Mislabeled Captura Serrated Forceps
Wilson-Cook Medical is recalling 6 units of Captura Serrated Forceps due to mislabeling that swapped spike and no-spike models.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 that could lead to the use of the wrong medical instrument, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 6 units of COOK MEDICAL Captura Serrated Forceps. The recall involves two specific models: the Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) and the Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S). The affected units are identified by Lot Number W4035257.
The recall was initiated because the products were mislabeled. Specifically, units of the Captura Serrated Forceps with Spike were incorrectly labeled as the No Spike model, and units of the Captura Serrated Large Forcep-No Spike were incorrectly labeled as the with Spike model. This labeling error could lead to the use of the wrong instrument during medical procedures.
The affected units were distributed in France, Ireland, and Japan. No specific dates or additional distribution details are provided in the source text. Healthcare providers and facilities that have received these products should verify the labeling against the lot number and model specifications to ensure the correct instrument is used.
The recalled product
- Product
- COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
- Manufacturer
- Wilson-Cook Medical Inc.
- Hazard
- Affected units
- 6
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 W4035257
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.
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