Recall archive
25 recalls · page 1 of 2
Reported Apr 29, 2026
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Product is mislabeled with the incorrect fill volume.
FDA (openFDA device enforcement)
Reported Jan 8, 2025
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to…
FDA (openFDA device enforcement)
Reported Aug 7, 2024
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of…
FDA (openFDA device enforcement)
Reported May 15, 2024
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
FDA (openFDA device enforcement)
Reported Apr 19, 2023
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized…
FDA (openFDA device enforcement)
Reported Nov 2, 2022
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and…
FDA (openFDA device enforcement)
Reported Oct 5, 2022
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the…
FDA (openFDA device enforcement)
Reported Oct 13, 2021
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand · Product · Product details — Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Reason for recall — AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2020
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand · Product · Product details — 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
FDA (openFDA device enforcement)
Reported Jun 24, 2020
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand · Reason for recall — Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2019
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — May result in readings outside of the expected accuracy range.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2019
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand · Product · Product details — The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which…
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand · Product details — Product was placed into distribution prior to completion of all required post sterilization release activities.
FDA (openFDA device enforcement)
Reported Feb 14, 2018
Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand — The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2017
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Product · Product details — The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Angiodynamics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 27, 2014
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand · Product details · Reason for recall — AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2013
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
Matched: Brand · Product · Product details · Reason for recall — AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro…
1 more product in this recall
FDA (openFDA device enforcement)
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