Recall of Soft-Vu Angiographic Catheter by Angiodynamics, Inc.
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Angiodynamics, Inc. is voluntarily recalling 1550 units of the Soft-Vu 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 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, fda, Devices.
What Happened
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter because the affected devices contain 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 recall involves the Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches; UDI-DI: 25051684007778 (Box), 15051684007771 (Pouch); Lot No.: A2425078, A3325036, A3525030, A3525031, A3725102. A total of 1550 units (155 boxes) are affected. The distribution was nationwide in the United States and also in 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. The official recall number is Z-1858-2026.
What You Should Do
Affected customers should follow the initial firm notification, which was issued via letter, and contact Angiodynamics, Inc. for further instructions regarding the recalled products.
Why This Matters
This recall addresses a potential safety issue with medical devices, helping to prevent complications during procedures and ensuring patient safety. It highlights the importance of quality control in healthcare products.
Source
Attribution: FDA. For more information, refer to the FDA recall notice with Event ID: 98463 on 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 (1,542 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.