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.

51–75 of 99

  • ModerateFDA (Devices)·Z-1335-2024·2024-03-27

    Angiodynamics Guidewire Introducer Devices Recalled for Manufacturing Defects

    Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical procedures.

    Product
    MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1338-2024·2024-03-27

    Vascular Guidewire Introducer Sheath Recall Due to Manufacturing Defect

    Angiodynamics is recalling certain MINI STICK MAX vascular guidewire introducer sheaths due to internal voids that may prevent guidewire passage during surgery, potentially causing procedural delays.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1336-2024·2024-03-27

    FDA Recalls Vascular Guidewire Introducer Due to Manufacturing Defect

    Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.

    Product
    MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1346-2024·2024-03-27

    Guidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect

    Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1339-2024·2024-03-27

    Angiodynamics surgical guidewire recalled for manufacturing defect

    Angiodynamics is recalling 5,176 units of MINI STICK MAX guidewires due to manufacturing voids that prevent passage through the introducer during surgery. Surgeons may need to exchange the sheath to complete procedures.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2024·2024-02-14

    PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks

    Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.

    Product
    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1381-2023·2023-04-19

    NanoKnife Surgical Probes Recalled Due to RFID Programming Error

    Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.

    Product
    NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0132-2023·2022-11-02

    Vortex MP Port Titanium Recalled for Missing Printed Instructions

    Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.

    Product
    Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2022·2022-10-05

    VenaCure EVLT procedure kit fiber component fails dimensional specification

    Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.

    Product
    VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2022·2021-10-13

    AngioDynamics NanoKnife Disposable Probes Recalled for Programming Issue

    AngioDynamics is recalling 37 NanoKnife Disposable Single Electrode Probes (Lot 5577754) due to a RFID programming issue that prevents the devices from being recognized by the NanoKnife generator.

    Product
    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2439-2021·2021-09-15

    Solero Generator PG requires software service for startup error

    Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.

    Product
    Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2436-2021·2021-09-15

    Solero MTA Generator requires software upgrade for startup error

    Angiodynamics is recalling specific refurbished Solero MTA Generators due to Error 0001, which occurs during system startup. A software upgrade is required to reduce the error's frequency.

    Product
    Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2021·2021-09-15

    Solero MTA Generator Requires Software Upgrade to Reduce Startup Error

    Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.

    Product
    Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2021·2021-09-15

    Solero MTA Generator refurbished units require software servicing

    Eight refurbished Solero MTA Generator units require software upgrades to reduce startup errors occurring in specific serial numbers.

    Product
    Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0418-2021·2020-11-11

    Angiodynamics 5F Micro-Introducer Kits Recalled for Incorrect Device Packaging

    Angiodynamics, Inc. is recalling 32 kits of 5F Standard Micro-Introducer Kits because they may contain a 4F Sheath/Dilator component instead of the correct device.

    Product
    Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2020·2020-06-24

    AngioDynamics PICC Kits Recalled Due to Defective BD Saline Flush Syringes

    AngioDynamics is recalling BioFlo and Xcela PICC Convenience Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2395-2020·2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2398-2020·2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Saline Flush Syringes

    AngioDynamics is recalling BioFlo and Xcela PICC kits because they contain BD saline flush syringes that were previously recalled by BD Medical.

    Product
    BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the samplin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2396-2020·2020-06-24

    AngioDynamics PICC Kits Recalled Due to Defective Saline Flush Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721 H96560M036708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2020·2019-12-25

    Angiodynamics Recalls OARtrac PLUS Clinical Detector Units Due to Accuracy Issues

    Angiodynamics, Inc. is recalling four OARtrac PLUS Clinical Detector Units because they may produce readings outside the expected accuracy range.

    Product
    OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2020·2019-12-25

    Angiodynamics Recalls 60 Micro-PSD HDR Radiation Therapy Sensors

    Angiodynamics, Inc. is recalling 60 Micro-PSD HDR sensors because they may provide readings outside the expected accuracy range.

    Product
    MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2020·2019-12-25

    Angiodynamics Recalls Micro-PSD External Beam Photon Sensors

    Angiodynamics, Inc. is recalling 48 Micro-PSD External Beam Photon sensors due to potential accuracy issues. The devices are used to measure radiation therapy during cancer treatment.

    Product
    MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0709-2020·2019-12-25

    Angiodynamics Recalls OARTRAC Prostate Balloon Kits Due to Accuracy Issues

    Angiodynamics, Inc. is recalling 160 OARTRAC Prostate Immobilization Endorectal Balloon Device Kits because they may produce readings outside the expected accuracy range.

    Product
    OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2020·2019-12-25

    Angiodynamics Recalls MICRO-PSD Electron Sensors Due to Accuracy Concerns

    Angiodynamics, Inc. is recalling 36 units of MICRO-PSD Electron sensors because they may provide readings outside the expected accuracy range.

    Product
    MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose rece
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2444-2019·2019-09-11

    AngioDynamics VenaCure EVLT NeverTouch Procedure Kit Recalled for RFID Error

    AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because an RFID programming error prevents the product from being used with the laser source.

    Product
    AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
    Category
    Medical Device
    Distribution
    8 states