FDA Recall of AccuVu Angiographic Catheter Due to Manufacturing Defect
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 recalling 105 units of the AccuVu Angiographic Catheter because of a defect that may prevent guidewires from passing through the device, affecting medical procedures.
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 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.
Recall of AccuVu Angiographic Catheter
What Happened
Angiodynamics, Inc. is recalling certain lots of 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, Pigtail, Non-Braided, With 21 R/O Markers; specifically, ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM. The catalog number is 13709804, with Product/UPN numbers H787137098045 (Box) and H787137098040 (Pouch). The UDI-DI numbers are 25051684006085 (Box) and 15051684006088 (Pouch). The recall involves Lot No. A2825131, with a total of 105 units (21 boxes). Distribution was nationwide in the United States 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 who have the affected products should contact Angiodynamics, Inc. for instructions, as the recall was initiated via letter. Stop using the affected devices and follow the firm's guidance for returns or replacements.
Why This Matters
This recall involves medical devices that could impact the safety and effectiveness of procedures, potentially leading to complications for patients in the United States and internationally.
Source
FDA recall notice Z-1875-2026
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 (1,536 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.