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Angiodynamics, Inc.

Angiodynamics, Inc. Recalls

All product recalls associated with Angiodynamics, Inc..

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Recall Summary

Total Recalls

58

Past Year

1

Class I (Serious)

0

Most Recent

Feb 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 58 recalls

IsoLoc Prostate Balloon (Angiodynamics) – mislabeled volume (2025)

Product is mislabeled with the incorrect fill volume.

FDAFeb 4, 2025Nationwide• Angiodynamics, Inc.

Auryon Laser System (Angiodynamics) – Procedural Delay Risk (2024)

Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.

FDANov 25, 2024Nationwide• Angiodynamics, Inc.

Soft-VU Kumpe 5F X 65CM (Angiodynamics) – Mislabeling Issue (2024)

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

FDAJun 18, 2024

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Nationwide

• Angiodynamics, Inc.

Soft-VU Kumpe 5F X 40CM (Angiodynamics) – Mislabeling Issue (2024)

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

FDAJun 18, 2024Nationwide• Angiodynamics, Inc.

IsoLoc Prostate Balloon (Angiodynamics) – Mislabeling Risk (2024)

A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).

FDAMay 21, 2024Nationwide• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for us...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicat...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- In...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indica...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicat...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for u...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for us...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- I...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- In...

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FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for us...

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Angiodynamics, Inc.: MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- U...

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.

Angiodynamics, Inc.: MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -U...

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.