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.
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 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 stand
- Manufacturer
- Cook Inc.
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 →Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02