The Recall Desk

Manufacturer

Angiodynamics, Inc.

99 recalls in our database name Angiodynamics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
99
Critical
0
Severe
3
Most recent
2026-04-29

Of the 99 recalls from Angiodynamics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–99 of 99

  • HighFDA (Devices)·Z-0742-2018·2018-03-07

    AngioDynamics Recalls Soft-Vu Omni Flush Angiographic Catheters

    AngioDynamics is recalling 28 Soft-Vu Omni Flush Angiographic Catheters because they were distributed before required post-sterilization release activities were completed.

    Product
    Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0528-2018·2018-02-14

    Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators

    Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators that may fail to deliver energy due to coolant ingress.

    Product
    Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperativ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2018·2018-02-14

    Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators

    Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.

    Product
    Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2018·2018-02-14

    Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators

    Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.

    Product
    Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2018·2018-02-14

    Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators Due to Malfunction

    Angiodynamics, Inc. is recalling 14,353 Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.

    Product
    Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0526-2018·2018-02-14

    Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators

    Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering desired microwave energy.

    Product
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0529-2018·2018-02-14

    Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators

    Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.

    Product
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

    AngioDynamics is recalling 996 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Component Defect

    AngioDynamics is recalling 80 boxes of Stiffened Micro-Introducer Kits because a component may detach during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2017·2016-12-28

    AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk

    AngioDynamics is recalling 751 Stiffened Micro-Introducer Kits because a component may detach during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

    AngioDynamics is recalling 7 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach from the hub during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2017·2016-12-28

    AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk

    AngioDynamics is recalling 145 boxes of Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

    AngioDynamics is recalling 4F Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches from the hub during use.

    Product
    ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0772-2017·2016-12-28

    AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk

    AngioDynamics is recalling 162 boxes of Stiffened Micro-Introducer Kits because the rotating luer may detach from the dilator hub during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H7870659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2016·2016-04-13

    AngioDynamics Recalls Renown Regional Medical Center Convenience Kits

    AngioDynamics is recalling 100 Renown Regional Medical Center Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.

    Product
    NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 136 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended 0.038-inch guidewire.

    Product
    NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 8 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.

    Product
    NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 45 NAMIC Convenience Kits because the needle inner lumen may be too small to accept a 0.038-inch guidewire.

    Product
    NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter ove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2261-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2014·2014-08-27

    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.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2013·2013-07-17

    AngioDynamics RITA Main Cable Recalled for Incorrect Instructions for Use

    AngioDynamics is recalling 13 RITA Main Cables because they contain incorrect Instructions for Use. The cables are used with RITA RF Generators and electrosurgical devices.

    Product
    AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1405-2013·2013-06-05

    AngioDynamics Recalls Micro Introducer Kits Due to Potential Size Mismatch

    AngioDynamics is recalling Micro Introducer Kits because the packaged sheath or dilator may be the incorrect French size.

    Product
    AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2013·2013-06-05

    AngioDynamics Recalls VenaCure EVLT NeverTouch Procedure Kits Due to Sizing Error

    AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because the packaged micro Introducer may be the wrong French size.

    Product
    AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide