FDA Recall of Angiodynamics' AccuVu Angiographic Catheter Due to Manufacturing Defect
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,403 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.