Angiodynamics recalls 5F Micro-Introducer Kits that may include a 4F Sheath/Dilator component, which could cause incorrect device use during vascular procedures.
“Angiodynamics 5F Micro-Introducer Kit Recall: Incorrect 4F Sheath Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64094-angiodynamics-5f-micro-introducer-kit-recall-incorrect-4f-sheath-risk. Based on FDA recall #Z-0418-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2021%22&limit=1).
Angiodynamics, Inc. voluntarily recalled its Angiodynamics 5F Standard Micro-Introducer Kit on Oct. 14, 2020, after the FDA announced the devices may contain incorrect components. The recall affects 32 kits distributed nationwide.
How to tell if you have it
Brand: Angiodynamics
Product: Angiodynamics 5F Standard Micro-Introducer Kit
Catalog Number: 06597035
UPN: H787065970355
Lot Number: 5626935
Expiration Date: 08/31/2023
The hazard
The Angiodynamics 5F Micro-Introducer Kits may not contain the correct device, as they were packaged with a 4F Sheath/Dilator component instead. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Angiodynamics, Inc. has had 18 other recalls since June 5, 2017. Recent examples include the Soft-Vu Angiographic Catheter Recall on March 3, 2026, and the Angiodynamics IsoLoc Prostate Balloon Kit recall on Feb. 4, 2025. Other recent recalls of similar products include the Arrow Percutaneous Sheath Introducer Recall (March 11, 2026), the Abiomed Intro Kit Recall (June 11, 2026), and the Micro Therapeutics Pipeline Flex Embolization Device recall (June 8, 2026).
How to tell if you have this one
Check the kit's catalog number (06597035) and lot number (5626935) on the packaging. The kit was sold between 2020 and 2023 with an expiration date of 08/31/2023.
Brand
Angiodynamics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Packaging
Look for the catalog number 06597035 and lot number 5626935 on the kit's packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of AL, CT, GA, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Connecticut, Florida, Georgia.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0418-2021 (October 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0418-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.