AngioDynamics Recalls Soft-Vu Angiographic Catheters Due to Mislabeled Pouches
AngioDynamics is recalling one lot of Soft-Vu angiographic catheters because a pouch inside the box may be mislabeled.
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 minor labeling error (mislabeled pouch) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
AngioDynamics is recalling one lot of Soft-Vu (JB-1) Non-braided angiographic catheters. The recall is due to a potential labeling error where one of the catheter pouches within the outer box may be mislabeled.
The affected product is the Soft-Vu (JB-1) Non-braided catheter, size 5F, length 100cm, designed to accept a .035 in. guidewire. The specific lot number is 564325, and the catalog number is 10734201. The products were packaged in boxes of 5 catheters each. The total quantity involved is 7 boxes, containing 35 units.
Distribution was worldwide, including the United States (nationwide, with specific mentions of CA, KS, MO, and NC) and the Czech Republic and Switzerland. The intended use for these devices is angiographic diagnosis. Healthcare facilities and distributors should check their inventory for this specific lot and stop using the affected units.
The recalled product
- Product
- AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA.…
- Manufacturer
- Angiodynamics Worldwide Headquarters
- Hazard
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: 564325
Distribution
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- SevereSoft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter, Omni Flush, Non-Braided recalled for manufacturing defect
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Omni Flush Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
FDA (Devices) · 2026-04-29
- HighAngiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
FDA (Devices) · 2026-04-29
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29