Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2313-2017·Announced 2017-06-14

Cook Medical Recalls Endoscopic Curved Needles Due to Reprocessing Instruction Deficiencies

Cook Medical is voluntarily recalling 725 units of endoscopic curved needles because the reprocessing instructions do not provide sufficient detail for proper cleaning and sterilization.

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 is a voluntary precautionary recall based on a documentation deficiency (insufficient reprocessing instructions) rather than a reported injury or contamination event.

Plain-English summary

Cook Medical is initiating a voluntary recall of 725 units of Endoscopic Curved Needle and Surgical Needle Guide products. The recall is being conducted because the reprocessing instructions supplied with the devices do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of the products.

The affected products were supplied sterilized by ethylene oxide gas in peel-open packages and are used for internal suturing under direct vision during intraabdominal endoscopic procedures. The recall covers 327 lots manufactured between January 2012 and February 2017.

Distribution was worldwide, including the United States and 26 other countries. Healthcare facilities and distributors should stop using the affected devices and contact Cook Medical for further instructions regarding the return or replacement of the products.

The recalled product

Product: Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of…
Manufacturer: Cook Inc.
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling
documentation-deficiency

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 (4)

CATALOG NUMBER: and GPN: J-ENH-033100 & G16426
J-ENH-053100 & G16427
J-ENH-053120 & G16428
J-ENH-053130 & G16429 Dates of Manufacture: January 2012 to February 2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Cook 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 6 products in this recall →

Same manufacturer · Cook Inc.

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Same hazard · mis labeling