Angiodynamics 5F Standard Micro-Introducer Kit — Class II medical device recall Z-0418-2021
Terminated recall by Angiodynamics, Inc., reported 2020-11-11, distributed nationwide. 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
| Recall number | Z-0418-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2020-10-14 |
| Classified | 2020-11-05 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2021-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 32 kits |
| UPC / GTIN / UDI-DI | 00787065970355 |
| Lot numbers | 5626935 |
| Model numbers | 06597035, H787065970355 |
| Expiration dates | 2023-08-31 |
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
Reason for recall
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0418-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.