FDA Recall Database: Class II Recall: Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP… by Angiodynamics, Inc.

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Angiodynamics, Inc. and the affected product is described in FDA's record as: Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;. FDA's stated reason for the recall is: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.. The recall is tracked under FDA recall number Z-1857-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches; -- and the recall number Z-1857-2026. If it matches, stop using or distributing it and contact Angiodynamics, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Angiodynamics, Inc.’s FDA history

Argus HQ has recorded 20 total FDA actions tied to Angiodynamics, Inc.: 0 warning letters, 20 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Angiodynamics, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 20 total FDA actions tied to Angiodynamics, Inc., including 20 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1857-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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