Angiodynamics, Inc. recalls
Every recall we track for Angiodynamics, Inc. — 82 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 7 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Angiodynamics, Inc. fell by more than half in 2025 (1, down from 34 in 2024). 9% rated “stop using now”.
All FDA recall records for Angiodynamics, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 6 | 1 | 7 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 6 | 0 | 6 |
| 2020 | 0 | 0 | 2 | 4 | 6 |
| 2021 | 0 | 0 | 4 | 0 | 4 |
| 2022 | 0 | 2 | 0 | 0 | 2 |
| 2023 | 0 | 1 | 1 | 0 | 2 |
| 2024 | 7 | 19 | 6 | 2 | 34 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 8 | 12 | 0 | 20 |
Most common reasons for Angiodynamics, Inc. recalls
What to do if you have a recalled Angiodynamics, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Angiodynamics, Inc. recalls
19 shown- Lower riskMedical device
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN
Angiodynamics recalls Soft-Vu Angiographic Catheters with a defect that may prevent guidewires from passing through the hub, risking procedure complications. Affected units include specific model numbers and lot codes.
AngiodynamicsMar 3, 2026 - Lower riskMedical device
Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Angiodynamics recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit (UPN/ISO-60) due to mislabeling with incorrect fill volume. Consumers should check product details to determine if affected.
AngiodynamicsFeb 4, 2025 - Lower riskMedical device
Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Angiodynamics recalls Auryon Laser System 100-120 VAC model EXM001 due to potential procedural delays during use. Affected units have specific product numbers and serial codes.
AngiodynamicsNov 25, 2024 - Lower riskMedical device
Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Angiodynamics recalls SOFT-VU KUMPE 5F X 40CM catheters due to potential mislabeling of inner pouch. This may cause incorrect catheter length use in angiographic procedures. Check your box and pouch labels for catalog number 10732702.
AngiodynamicsJun 18, 2024 - Lower riskMedical device
Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Angiodynamics recalls IsoLoc Prostate Immobilization Balloon Kit (ISO-100) due to mislabeling causing potential wrong size use. Affected units have specific lot numbers and UDI codes.
AngiodynamicsMay 21, 2024 - Use cautionMedical device
Angiodynamics, Inc. recalls DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and
Angiodynamics recalls DURAFLOW 2 32cm Straight Basic Kit for hemodialysis access due to potential metal shavings that could cause surgical removal. Affected units have specific product numbers and lot numbers.
AngiodynamicsMar 18, 2024 - Use cautionMedical device
Angiodynamics, Inc. recalls 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
Angiodynamics recalls MINI STICK MAX 5F X 10 CM surgical sheaths due to potential voids causing guidewire blockage, risking procedure delays. Affected units have specific catalog and lot numbers.
AngiodynamicsJan 30, 2024 - Use cautionMedical device
Angiodynamics, Inc. recalls PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray
Angiodynamics recalls PulseSpray Infusion Systems with a manufacturing defect that may cause medication leaks during use. Affected models include PULSE SPRAY 5F/135/20 and others. Stop using immediately to prevent potential medication leaks.
AngiodynamicsDec 18, 2023 - Lower riskMedical device
Angiodynamics, Inc. recalls NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog
Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to RFID programming errors that prevent probes from being recognized by the generator, causing procedure delays. Affected units include specific catalog and lot numbers.
AngiodynamicsMar 2, 2023 - Use cautionMedical device
Angiodynamics, Inc. recalls Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central
Angiodynamics recalls Vortex MP Port devices due to missing instructions for use, which could lead to patient injury if not followed properly. Affected units include specific model numbers and lot numbers.
AngiodynamicsSep 20, 2022 - Use cautionMedical device
Angiodynamics, Inc. recalls VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For
Angiodynamics recalls VenaCure EVLT Procedure Kits with Spotlight Ops Sheath 55cm (EVLT55OPS) due to potential sheath damage causing procedural delays or surgery. Affected kits have specific UDI-DI and lot numbers.
AngiodynamicsAug 10, 2022 - Lower riskMedical device
Angiodynamics, Inc. recalls Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Angiodynamics recalls Solero MTA Generator units with specific serial numbers requiring software update to prevent Error 0001 during startup. Affected units must be serviced by authorized technicians.
AngiodynamicsJul 20, 2021 - Lower riskMedical device
Angiodynamics, Inc. recalls Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter
Angiodynamics recalls 5F Micro-Introducer Kits that may include a 4F Sheath/Dilator component, which could cause incorrect device use during vascular procedures.
AngiodynamicsOct 14, 2020 - UnratedMedical device
Angiodynamics, Inc. recalls BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of
Angiodynamics recalls BioFlo Midline Convenience Kits containing BD PosiFlush SF Saline Flush Syringes from April 2020 due to BD's recall. Affected units include specific item numbers and lots.
AngiodynamicsMay 4, 2020 - Lower riskMedical device
Angiodynamics, Inc. recalls AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single
Angiodynamics recalls 15 cm IRE Single Electrode Probes due to RFID programming issue preventing recognition by the generator. Affected units may not function properly during medical procedures.
AngiodynamicsApr 24, 2020 - Lower riskMedical device
Angiodynamics, Inc. recalls OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated
Angiodynamics recalls prostate immobilization balloon kits with catalog number ORB-60F due to potential inaccurate radiation therapy readings. Affected units were sold with specific lot numbers and UDI codes.
AngiodynamicsNov 19, 2019 - Lower riskMedical device
Angiodynamics, Inc. recalls AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Angiodynamics recalls VenaCure EVLT NeverTouch Procedure Kit due to RFID expiration date error causing product incompatibility with laser systems.
AngiodynamicsJun 27, 2019 - UnratedMedical device
Angiodynamics, Inc. recalls Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201
Angiodynamics recalls Soft-Vu Omni Flush Angiographic Catheters due to incomplete post-sterilization release activities. Affected units may have safety risks during medical procedures.
AngiodynamicsSep 22, 2017 - Lower riskMedical device
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is
Angiodynamics recalls Accu2i pMTA Applicators with potential microwave energy failure due to coolant ingress causing error codes. Affected units include specific model numbers and lots.
AngiodynamicsJun 5, 2017
Angiodynamics, Inc. recall questions
How many recalls has Angiodynamics, Inc. had?
82 recalls from Angiodynamics, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Angiodynamics, Inc. recall?
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN, dated Mar 3, 2026. Every Angiodynamics, Inc. recall is listed on this page, newest first.
Why are Angiodynamics, Inc. products recalled?
The most common reasons on record: May result in readings outside of the expected accuracy range. (5).
What should I do if I have a recalled Angiodynamics, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Angiodynamics, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.