Class II — Angiodynamics, 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 | 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component |
| Product | Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355 |
| Quantity | 32 kits |
| Distribution | US Nationwide distribution including in the states of AL, CT, GA, FL. |
| Initiated | 2020-10-14 |
| Classified | 2020-11-05 |
| Terminated | 2021-10-19 |
| Recall number | Z-0418-2021 |
| 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. (Z-0418-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86627/
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