Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)

78 recalls in our database name Angiodynamics Inc. (Navilyst Medical Inc.) as the manufacturing or recalling firm.

What the numbers show

Total: 78
Critical: 0
Severe: 27
Most recent: 2021-10-06

Of the 78 recalls from Angiodynamics Inc. (Navilyst Medical Inc.) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (35%) 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.

1–25 of 78

ModerateFDA (Devices)·Z-2617-2021·2021-10-06
Xcela PICC catheter mislabeled with incorrect size designation
Angiodynamics is recalling Xcela PICC catheters where units labeled as 5F are actually 4F. The labeling discrepancy between labeled and actual product size could affect clinical device selection.
Product
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-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
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1467-2021·2021-04-28
AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.
Product
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2021·2021-04-28
AngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
AngioDynamics is recalling specific lots of Smart Port CT-Implantable Port kits due to potential compromised sterility. The recall affects 267 kits distributed nationwide.
Product
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and pow
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0503-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Plastic Non-Filled Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2020·2019-11-27
Angiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect
Angiodynamics Inc. is recalling 582 XCELA implantable port kits because snap lock connectors may not meet specifications, preventing catheter insertion.
Product
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood product
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0502-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Titanium Non-Filled Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Titanium Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood produc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0504-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
Angiodynamics Inc. is recalling BIOFLO 8F catheters because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0411-2020·2019-11-27
Angiodynamics Recalls Mislabelled Starburst Electrosurgical Devices
Angiodynamics Inc. is recalling 30 Starburst Talon Semi-Flex Electrosurgical Devices that were incorrectly labelled as Starburst MRI Semi-Flex devices, potentially causing procedural delays.
Product
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0501-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Filled Non-Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1701-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 178 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1704-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Procedure Delay Risk
AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedure Risk
AngioDynamics is recalling Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from delayed procedures via manual and software updates.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1700-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 7,348 Solero Microwave Tissue Ablation applicators to update manuals and software, reducing the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablati
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0595-2019·2018-12-19
Angiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates
Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with expiration dates that extend shelf life beyond validated testing.
Product
Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0596-2019·2018-12-19
BioFlo PICC Recall Issued for Incorrect Expiration Date Labeling
Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.
Product
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0076-2019·2018-10-17
AngioDynamics BioFlo Port Recall Due to Incorrect Sterile Assembly
AngioDynamics is recalling BioFlo Ports that were partially manufactured with the wrong sterile port assembly. The devices were distributed in Indiana.
Product
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2202-2018·2018-06-20
Angiodynamics Recalls Bioflo Midline Catheters Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters because a component may contain unsafe levels of bacterial endotoxins.
Product
RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2192-2018·2018-06-20
Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk
Angiodynamics Inc. is recalling 17 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Product
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2211-2018·2018-06-20
Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling 11 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
Product
RS 5F DL BIOFLO PASV, Catalog Number 60M181578
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2208-2018·2018-06-20
Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling 7 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
Product
RS 5F DL BIOFLO PASV, Catalog Number 60M150373
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2189-2018·2018-06-20
Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk
Angiodynamics Inc. is recalling 50 boxes of Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.
Product
Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2218-2018·2018-06-20
Angiodynamics Recalls XCELA PICC Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Product
CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2196-2018·2018-06-20
Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk
Angiodynamics Inc. is recalling 298 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Product
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2217-2018·2018-06-20
Angiodynamics Recalls PICC Nursing Trays Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 2 boxes of CAN 5F DL BIOFLO PASV PICC Nursing Trays because a component may contain unsafe levels of bacterial endotoxins.
Product
CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
Category
Medical Device
Distribution
34 states