PlainRecalls

Angiodynamics Inc. (Navilyst Medical Inc.)

Compiled from official public sources by the editorial team.

78 recalls on record · Latest: Oct 6, 2021

Angiodynamics Inc. (Navilyst Medical Inc.) Recall Insight

Angiodynamics Inc. (Navilyst Medical Inc.) appears on 78 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.077% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 6, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jun 20, 2018 to Oct 6, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 6, 2021

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 …

FDA Devices Moderate Apr 28, 2021

AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various ty…

FDA Devices Moderate Apr 28, 2021

Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vasc…

FDA Devices Moderate Nov 27, 2019

BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for adm…

FDA Devices Moderate Nov 27, 2019

BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022

FDA Devices Moderate Nov 27, 2019

BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for admin…

FDA Devices Moderate Nov 27, 2019

XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for admi…

FDA Devices Moderate Nov 27, 2019

BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for admin…

FDA Devices Moderate Nov 27, 2019

Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, …

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Gen…

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)So…

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Soler…

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 …

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Sol…

FDA Devices Moderate Dec 19, 2018

Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711

FDA Devices Moderate Dec 19, 2018

BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481

FDA Devices Moderate Oct 17, 2018

BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box…

FDA Devices Moderate Jun 20, 2018

CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531

FDA Devices Moderate Jun 20, 2018

5F DL BIOFLO PASV, Catalog Number 60M141006

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M132324

FDA Devices Moderate Jun 20, 2018

BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL XPP, Catalog Number 60M019881

FDA Devices Moderate Jun 20, 2018

5F DL BIOFLO PICC, Catalog Number 60M180592

FDA Devices Moderate Jun 20, 2018

BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032

FDA Devices Moderate Jun 20, 2018

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M150373

FDA Devices Moderate Jun 20, 2018

Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M181578

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PICC, Catalog Number 60M071831

FDA Devices Moderate Jun 20, 2018

BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

FDA Devices Moderate Jun 20, 2018

XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887

FDA Devices Moderate Jun 20, 2018

RS 5F DL XPP KIT, Catalog Number 60M183104

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

FDA Devices Moderate Jun 20, 2018

CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M183481

FDA Devices Moderate Jun 20, 2018

RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

FDA Devices Moderate Jun 20, 2018

RS 5F DL XCELA PICC, Catalog Number 60M122272

FDA Devices Moderate Jun 20, 2018

BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019

FDA Devices Moderate Jun 20, 2018

TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196

FDA Devices Moderate Jun 20, 2018

BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038

FDA Devices Moderate Jun 20, 2018

RS 5F DL XPP, Catalog Number 60M030393

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Angiodynamics Inc. (Navilyst Medical Inc.) with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.