Recall of AccuVu Angiographic Catheter Issued
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Angiodynamics, Inc. is recalling 500 units of the AccuVu Angiographic Catheter due to a manufacturing defect that may prevent guidewires from passing through.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 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 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
Angiodynamics, Inc. is recalling the AccuVu Angiographic Catheter due to a manufacturing defect that 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 21 R/O Markers; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); UDI-DI: 25051684006030 (Box), 15051684006033 (Pouch); Lot No.: A3025039 and A3225033. A total of 500 units (100 boxes) are affected, with distribution in the United States nationwide and internationally 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 stop using the affected devices and contact Angiodynamics, Inc. for instructions, as the recall was initiated via letter.
Why This Matters
This recall highlights potential risks in medical devices that could affect procedural safety, emphasizing the importance of device reliability in healthcare.
Source
This recall is documented by the FDA with Recall Number: Z-1874-2026. For more information, refer to the FDA website.
Original source: FDA Official Notice ↗
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