AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error
AngioDynamics is recalling specific Uni*Fuse Infusion Systems because they may contain a guidewire that is too long. The recall covers 36 units distributed in the US and internationally.
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 medical device with a potential defect (incorrect guidewire size) where no injuries or illnesses have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AngioDynamics, Inc. is recalling specific units of the Uni*Fuse Infusion System with Cooper Wire. The recall is being conducted because the company became aware that these systems have the potential to contain an incorrectly sized guidewire that is too long.
The affected product is the Uni*Fuse Infusion System with Cooper Wire, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095. The recall involves Lot 4762513, which has an expiration date of May 31, 2017. A total of 36 units were distributed domestically in the United States and internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
The source text does not specify any reported illnesses, injuries, or deaths associated with this recall. The hazard is identified as a potential manufacturing defect regarding the length of the guidewire.
The recalled product
- Product
- Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Infusion System
- Affected units
- 36
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 4762513 (exp. date 31-May-17)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Angiodynamics, 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 3 products in this recall →Related recalls
Same manufacturer · Angiodynamics, Inc.
See all →- HighAngiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
FDA (Devices) · 2026-04-29
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
FDA (Devices) · 2026-04-29
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateGuidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect
FDA (Devices) · 2024-03-27
- ModerateAngiodynamics Guidewire Introducer Devices Recalled for Manufacturing Defects
FDA (Devices) · 2024-03-27
- ModerateAngiodynamics surgical guidewire recalled for manufacturing defect
FDA (Devices) · 2024-03-27
- HighAngiodynamics Guidewire Introducer Recall Due to Manufacturing Defect
FDA (Devices) · 2024-03-27
- HighGuidewire Introducer Recalled for Manufacturing Defect Affecting Device Function
FDA (Devices) · 2024-03-27
- ModerateGuidewire Introducer Sheath with Manufacturing Defect Recalled by Angiodynamics
FDA (Devices) · 2024-03-27