Angiodynamics Inc. (Navilyst Medical Inc.)
Complete recall history across all FDA and CPSC categories — 78 total recalls
Angiodynamics Inc. (Navilyst Medical Inc.) appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (78)
FDA medical device enforcement actions by Angiodynamics Inc. (Navilyst Medical Inc.). Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 22, 2021 | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantabl... | Class II |
| Feb 22, 2021 | AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantabl... | Class II |
| Oct 2, 2019 | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 ... | The devices are not labelled correctly. End users impacted by this issue may... | Class II |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 ... | Snap lock connectors provided within implantable port kits may not meet dimen... | Class II |
| Sep 18, 2019 | XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040... | Snap lock connectors provided within implantable port kits may not meet dimen... | Class II |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 ... | Snap lock connectors provided within implantable port kits may not meet dimen... | Class II |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 | Snap lock connectors provided within implantable port kits may not meet dimen... | Class II |
| Sep 18, 2019 | BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-02... | Snap lock connectors provided within implantable port kits may not meet dimen... | Class II |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and So... | Class II |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero G... | Updated Warning Statements in the Operator's Manual/Directions for Use and So... | Class II |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and So... | Class II |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Appl... | Updated Warning Statements in the Operator's Manual/Directions for Use and So... | Class II |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generat... | Updated Warning Statements in the Operator's Manual/Directions for Use and So... | Class II |
| Oct 16, 2018 | BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL ... | specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with in... | Class II |
| Oct 16, 2018 | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE ... | Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with in... | Class II |
| Jul 24, 2018 | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PL... | BioFlo Ports was partially manufactured with the incorrect sterile port assem... | Class II |
| May 10, 2018 | Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M161567 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalo... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL XPP, Catalog Number 60M030393 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wir... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL XCELA PICC, Catalog Number 60M122272 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M183481 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Nu... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL XPP KIT, Catalog Number 60M183104 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidew... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL BIOFLO PICC, Catalog Number 60M071831 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M181578 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M150373 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire P... | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | 5F DL BIOFLO PICC, Catalog Number 60M180592 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
| May 10, 2018 | RS TANDEM 5F DL XPP, Catalog Number 60M019881 | A component of the kits might contain unsafe levels of bacterial endotoxins (... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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