Recall archive
13 recalls · page 1 of 1
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand — Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Reason for recall — AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2019
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand — The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Product · Product details — Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 19, 2018
Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand — Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 17, 2018
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Product · Product details — BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus…
FDA (openFDA device enforcement)
Reported Jun 20, 2018
XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand — A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
37 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 25, 2018
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand — NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the…
FDA (openFDA device enforcement)
Reported Dec 20, 2017
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Reason for recall — Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2017
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand — The product has the potential to be non-sterile as it was not packaged in accordance to specification.
FDA (openFDA device enforcement)
Reported Feb 15, 2017
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Product · Product details — The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not…
FDA (openFDA device enforcement)
Reported Dec 14, 2016
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Reason for recall — Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2016
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Product · Product details · Reason for recall — Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed…
1 more product in this recall
FDA (openFDA device enforcement)
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