Angiodynamics, Inc.
United StatesFDA applicant, unverified FDA FEI 1319211
- Devices
- 2,347
- Registrations
- FDA
- FDA recalls
- 23659 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Angiodynamics, Inc. makes
Angiodynamics produces single-use angiographic catheters, vascular catheter introduction sets, and peripheral vascular intervention infusion catheters for diagnostic and therapeutic vascular procedures. Their portfolio includes vascular ports and catheters, such as implantable double-lumen haemodialysis catheters, as well as peripheral vascular guidewires and non-bioabsorbable closed-wound drains. Electrocardiographic central venous catheter navigation systems and specialized vascular access devices like the Smart Port CT and BioFlo Vortex are also part of their offerings.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Angiodynamics is headquartered in the United States.
Catalogue
Search and filter all 2,347 devicesShowing 1-50 of 2,347
Company details
- FDA FEI number
- 1319211
- DUNS number
- 079105071
- Address
- 603 QUEENSBURY AVE., Queensbury, NY, 12804
- Phone
- +1(518)795-1676
FDA recalls
FDA recall records list 1 recall initiated by ANGIODYNAMICS, INC., initiated on 2014-12-19. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 9
- 2018 42
- 2019 17
- 2020 6
- 2021 6
- 2022 2
- 2023 2
- 2024 34
- 2025 1
- 2026 20
2026
- 3 Mar 2026 Z-1856-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1857-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1858-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1859-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1860-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1861-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1862-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1863-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1864-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1865-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1856-2026 Class II Ongoing 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.
Show the 25 most recent of 236 recalls
2026
- 3 Mar 2026 Z-1866-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1867-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1868-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1869-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1870-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1871-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1872-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1873-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1874-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1875-2026 Class II Ongoing 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.
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- 3 Mar 2026 Z-1866-2026 Class II Ongoing 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.
2025
- 4 Feb 2025 Z-1391-2025 Class II Ongoing Product is mislabeled with the incorrect fill volume.
2024
- 25 Nov 2024 Z-0770-2025 Class II Ongoing 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.
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- 18 Jun 2024 Z-2453-2024 Class II Ongoing 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)
- 18 Jun 2024 Z-2454-2024 Class II Ongoing 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)
- 21 May 2024 Z-2267-2024 Class II Ongoing 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).
- 25 Nov 2024 Z-0770-2025 Class II Ongoing 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.
Sites
- Angiodynamics, Inc USFEI 3017892510 0 devices
Frequently asked questions
How many devices does ANGIODYNAMICS, INC. have in the registry?
The registry currently lists 2347 devices for ANGIODYNAMICS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ANGIODYNAMICS, INC.'s devices?
Among its 50 most recently registered devices, ANGIODYNAMICS, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do ANGIODYNAMICS, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ANGIODYNAMICS, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ANGIODYNAMICS, INC.?
FDA recall records list 236 recalls initiated by ANGIODYNAMICS, INC., the most recent initiated on 3 Mar 2026. 59 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ANGIODYNAMICS, INC. in the registry?
The most recently registered devices listed for ANGIODYNAMICS, INC. include AngioDynamics H787TDST0, AngioDynamics H787065200010, NanoKnife H78720300301US0 and NanoKnife H787204001090.