Queensbury, NY, United States
Angiodynamics, Inc. recalls
19 recalls recorded since 2018, most recently on 3 March 2026. 11 are listed as ongoing. Status and classification are as published by the FDA.
Recalls19
Ongoing (FDA)11
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 March 2026
- Reason
- The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1862-2026, Z-1873-2026, Z-1863-2026, Z-1866-2026, Z-1872-2026, Z-1859-2026, Z-1871-2026, Z-1858-2026, Z-1860-2026, Z-1864-2026, Z-1875-2026, Z-1870-2026 and 8 more
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
- AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouc
- Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
- AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity:
- Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
- Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
- and 12 more product lines
Ongoing Class II Medical devices
- Recall started
- 4 February 2025
- Reason
- Product is mislabeled with the incorrect fill volume.
- Distribution
- US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1391-2025
- IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Ongoing Class II Medical devices
- Recall started
- 25 November 2024
- Reason
- Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
- Distribution
- US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, RI, TN, TX, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0770-2025
- AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Ongoing Class II Medical devices
- Recall started
- 18 June 2024
- Reason
- Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2453-2024, Z-2454-2024
- SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
- SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Ongoing Class II Medical devices
- Recall started
- 21 May 2024
- Reason
- 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 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
- Distribution
- US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2267-2024
- IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Ongoing Class II Medical devices
- Recall started
- 18 March 2024
- Reason
- Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Distribution
- VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1762-2024, Z-1770-2024, Z-1766-2024, Z-1768-2024, Z-1760-2024, Z-1763-2024, Z-1774-2024, Z-1771-2024, Z-1773-2024, Z-1765-2024, Z-1769-2024, Z-1764-2024 and 3 more
- DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
- DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
- DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
- DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
- DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
- DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
- BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
- DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
- and 7 more product lines
Ongoing Class II Medical devices
- Recall started
- 30 January 2024
- Reason
- Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Distribution
- Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1346-2024, Z-1345-2024, Z-1335-2024, Z-1339-2024, Z-1334-2024, Z-1337-2024, Z-1341-2024, Z-1343-2024, Z-1336-2024, Z-1348-2024, Z-1344-2024, Z-1340-2024 and 3 more
- 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
- MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
- 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
- MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
- 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 vascular system. Catalog Number: 45-749
- MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
- MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
- MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
- and 7 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 December 2023
- Reason
- Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
- Distribution
- United States (MD, LA & UT), Austria, Canada and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1010-2024
- 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: 12500
Ongoing Class II Medical devices
- Recall started
- 2 March 2023
- Reason
- Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
- Distribution
- US Nationwide Distribution: CA,CO, FL, IA, NY, OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1381-2023
- NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Ongoing Class II Medical devices
- Recall started
- 20 September 2022
- Reason
- Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.
- Distribution
- US Nationwide distribution in the states of AZ, CA, DC, IN, PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0132-2023
- 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
Ongoing Class II Medical devices
- Recall started
- 10 August 2022
- Reason
- OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention
- Distribution
- US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1819-2022
- 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.
Terminated Class II Medical devices
- Recall started
- 20 July 2021
- Terminated
- 15 March 2023
- Reason
- Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
- Distribution
- Domestic distribution Nationwide. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2437-2021, Z-2436-2021, Z-2438-2021, Z-2439-2021
- Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
- Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
- Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
- Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
Terminated Class II Medical devices
- Recall started
- 14 October 2020
- Terminated
- 19 October 2021
- Reason
- 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
- Distribution
- US Nationwide distribution including in the states of AL, CT, GA, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0418-2021
- Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
Terminated Class II Medical devices
- Recall started
- 4 May 2020
- Terminated
- 23 August 2023
- Reason
- Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2396-2020, Z-2398-2020, Z-2397-2020, Z-2395-2020
- 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 H
- 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 admi
- 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 o
- 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 vascula
Terminated Class II Medical devices
- Recall started
- 24 April 2020
- Terminated
- 20 September 2022
- Reason
- Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
- Distribution
- Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0073-2022
- AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Terminated Class II Medical devices
- Recall started
- 19 November 2019
- Terminated
- 26 October 2020
- Reason
- May result in readings outside of the expected accuracy range.
- Distribution
- US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0709-2020, Z-0710-2020, Z-0712-2020, Z-0711-2020, Z-0713-2020
- 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 t
- 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
- 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 permi
- 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
- 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 treatme
Terminated Class II Medical devices
- Recall started
- 27 June 2019
- Terminated
- 29 July 2020
- Reason
- The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.
- Distribution
- The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2444-2019
- AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Terminated Class II Medical devices
- Recall started
- 22 September 2017
- Terminated
- 19 September 2018
- Reason
- Product was placed into distribution prior to completion of all required post sterilization release activities.
- Distribution
- US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0742-2018
- 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.
Terminated Class II Medical devices
- Recall started
- 5 June 2017
- Terminated
- 11 September 2018
- Reason
- 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 microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
- Distribution
- Worldwide distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0531-2018, Z-0528-2018, Z-0529-2018, Z-0530-2018, Z-0527-2018, Z-0526-2018
- 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 Microw
- 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 T
- 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
- 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 Tiss
- 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 A
- 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 Tissu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.