Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.
Plain-English summary
Cook Inc. is recalling Torcon NB Advantage Catheters because of a potential compromise of the sterility of the products. The issue stems from undersealed chevron in the packaging pouches.
The affected products are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures by physicians trained and experienced in angiographic techniques. The recall involves 5 units distributed worldwide and nationwide in the United States, including specific states and Puerto Rico, as well as in numerous international countries.
Healthcare providers and facilities should stop using the affected catheters and contact Cook Inc. for further instructions. The specific lot number is NS9928939, with Reference Number HNB5.0-38-75-P-NS-C1 and GPN G27702.
The recalled product
- Product
- Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 5
Distribution
Part of a larger recall action
This product is one of 71 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 71 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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters
FDA (Devices) · 2015-08-12
- SevereCook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture
FDA (Devices) · 2016-08-31
- HighCook Newton Wire Guide Recalls Due to Potential Sterility Compromise
FDA (Devices) · 2022-10-05
- HighMedical Guidewire Recalled for Packaging Defect Affecting Sterility
FDA (Devices) · 2022-10-05
- HighCoons Interventional Guidewire Recall Due to Packaging Sterility Breach
FDA (Devices) · 2022-10-05
- SevereCook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk
FDA (Devices) · 2016-08-31