FDA Recall of Angiodynamics' AccuVu Angiographic Catheter Due to Manufacturing Defect
Angiodynamics, Inc. is recalling 515 units of its AccuVu Angiographic Catheter because of a defect that may prevent guidewires from passing through the catheter hub, affecting distribution in the US and internationally.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
The recall is due to a manufacturing defect in the affected devices, which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.
Which Products Are Affected
The affected products are the AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); with UDI-DI: 25051684005712 (Box), 15051684005715 (Pouch); and Lot Nos.: A2725033, A2725034, A3525048, A3525049. A total of 515 units (103 boxes) are involved, distributed nationwide in the US and to countries including Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, and Thailand.
What You Should Do
Consumers and healthcare providers should contact the recalling firm, Angiodynamics, Inc., via the initial notification letter for instructions on returns or refunds. The firm's address is 603 Queensbury Ave, Queensbury, NY 12804-7619.
Why This Matters
This recall involves medical devices that could affect procedures if the defect occurs, potentially leading to complications, though the overall risk is classified as Class II by the FDA.
Source
FDA Recall Notice: Z-1872-2026. For more information, refer to the FDA website.
Original source: FDA Official Notice ↗
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