Angiodynamics 5F Micro-Introducer Kits Recalled for Incorrect Device Packaging
Angiodynamics, Inc. is recalling 32 kits of 5F Standard Micro-Introducer Kits because they may contain a 4F Sheath/Dilator component instead of the correct device.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a packaging error where the wrong device component is included. No injuries or illnesses are reported in the source text, and the hazard is a potential procedural error rather than a direct toxic or structural failure.
Plain-English summary
Angiodynamics, Inc. is recalling 32 kits of the 5F Standard Micro-Introducer Kit (Catalog Number: 06597035, Lot Number: 5626935, Expiration Date: 08/31/2023). The recall is due to a packaging error where the kits may contain a 4F Sheath/Dilator component instead of the correct device. The product is indicated for the percutaneous introduction of a guidewire or catheter into the vascular system.
The affected products were distributed nationwide in the United States, including in the states of Alabama, Connecticut, Georgia, and Florida. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and distributors should stop using the affected kits and contact Angiodynamics, Inc. for instructions on return or replacement. Patients who have received the affected product should contact their healthcare provider for evaluation.
The recalled product
- 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
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 5626935 Expiration Date: 08/31/2023
Distribution
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