Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall affects units distributed worldwide and in the US.
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 (sterility compromise) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Cook Inc. is recalling Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron packaging pouches, which may allow contamination of the medical devices.
The affected product is intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures. The recall covers five units with Lot Number NS9930287 and UDI (01)00827002125179(17)220812(10)NS9930287.
Distribution was worldwide, including the United States and various international countries. Healthcare providers and facilities should check their inventory for this specific lot number and stop using the affected catheters if found.
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
- 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 Inc. Recalls Neff Percutaneous Access Sets Due to Sterility Concerns
FDA (Devices) · 2019-06-19
- SevereCook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk
FDA (Devices) · 2016-08-31
- ModerateCook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Fit Issues
FDA (Devices) · 2018-02-21
- SevereCook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk
FDA (Devices) · 2016-03-02