Navilyst Medical, Inc., an AngioDyamics Company

Complete recall history across all FDA and CPSC categories — 23 total recalls

Navilyst Medical, Inc., an AngioDyamics Company 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 (23)

FDA medical device enforcement actions by Navilyst Medical, Inc., an AngioDyamics Company

Date Product Reason Class
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Ki... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M0014... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H96595... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H96595... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M0014... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55c... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, R... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels:... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H9654... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... Class II
Mar 14, 2016 Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.