Angiodynamics Recalls
100 recalls on record · June 5, 2013 to April 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 15, 2021Medical DevicesFDA
Angiodynamics, Inc. recalls Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
Hazard: 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.
September 15, 2021Medical DevicesFDA
Angiodynamics, Inc. recalls Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Hazard: 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.
September 15, 2021Medical DevicesFDA
Angiodynamics, Inc. recalls Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Hazard: 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.
September 15, 2021Medical DevicesFDA
Angiodynamics, Inc. recalls Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Hazard: 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.
November 11, 2020Medical DevicesFDA
Angiodynamics, Inc. recalls Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter int
Hazard: 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
June 24, 2020Medical DevicesFDA
Angiodynamics, Inc. recalls BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral
Hazard: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
June 24, 2020Medical DevicesFDA
Angiodynamics, Inc. recalls BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to t
Hazard: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
June 24, 2020Medical DevicesFDA
Angiodynamics, Inc. recalls BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnos
Hazard: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
June 24, 2020Medical DevicesFDA
Angiodynamics, Inc. recalls BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous
Hazard: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
December 25, 2019Medical DevicesFDA
Angiodynamics, Inc. recalls MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for us
Hazard: May result in readings outside of the expected accuracy range.
December 25, 2019Medical DevicesFDA
Angiodynamics, Inc. recalls MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer t
Hazard: May result in readings outside of the expected accuracy range.
December 25, 2019Medical DevicesFDA
Angiodynamics, Inc. recalls MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during can
Hazard: May result in readings outside of the expected accuracy range.
December 25, 2019Medical DevicesFDA
Angiodynamics, Inc. recalls OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intende
Hazard: May result in readings outside of the expected accuracy range.
December 25, 2019Medical DevicesFDA
Angiodynamics, Inc. recalls OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated
Hazard: May result in readings outside of the expected accuracy range.
September 11, 2019Medical DevicesFDA
Angiodynamics, Inc. recalls AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Hazard: 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.
March 7, 2018Medical DevicesFDA
Angiodynamics, Inc. recalls Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 A
Hazard: Product was placed into distribution prior to completion of all required post sterilization release activities.
February 14, 2018Medical DevicesFDA
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is
Hazard: 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.
February 14, 2018Medical DevicesFDA
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for
Hazard: 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.
February 14, 2018Medical DevicesFDA
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is onl
Hazard: 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.
February 14, 2018Medical DevicesFDA
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only
Hazard: 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.
February 14, 2018Medical DevicesFDA
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use
Hazard: 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.
February 14, 2018Medical DevicesFDA
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for
Hazard: 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.
December 28, 2016Medical DevicesFDA
Angiodynamics, Inc. recalls ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutane
Hazard: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
December 28, 2016Medical DevicesFDA
Angiodynamics, Inc. recalls ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T N
Hazard: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
December 28, 2016Medical DevicesFDA
Angiodynamics, Inc. recalls ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T N
Hazard: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
December 28, 2016Medical DevicesFDA
Angiodynamics, Inc. recalls ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T E
Hazard: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
December 28, 2016Medical DevicesFDA
Angiodynamics, Inc. recalls ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T E
Hazard: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
December 28, 2016Medical DevicesFDA
Angiodynamics, Inc. recalls ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T E
Hazard: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
December 28, 2016Medical DevicesFDA
Angiodynamics, Inc. recalls ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS
Hazard: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
April 13, 2016Medical DevicesFDA
AngioDynamics Inc. recalls NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 P
Hazard: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".