Class II — Angiodynamics Inc. (Navilyst Medical Inc.)
| Recalling firm | ANGIODYNAMICS, INC |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| Product | RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 |
| Quantity | 15 boxes |
| Distribution | 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. |
| Initiated | 2018-05-10 |
| Classified | 2018-06-14 |
| Terminated | 2020-05-13 |
| Recall number | Z-2216-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Angiodynamics Inc. (Navilyst Medical Inc.) (Z-2216-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80169/
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