Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2018 - (Recall #: Z-2198-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 10, 2018

Date Posted: June 20, 2018

Recall Number: Z-2198-2018

Event ID: 80169

Reason for Recall:

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Status: Terminated

Product Quantity: 190 boxes

Code Information:

UPN: H965464901; Lot: 5302405, 5312036, 5314940

Distribution Pattern:

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated