Manufacturer

Angiodynamics, Inc.

64 recalls in our database name Angiodynamics, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 64

SevereFDA (Devices)·Z-1869-2026·2026-04-29
Soft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect
Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter (Straight Art, Non-Braided) units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
Product
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2026·2026-04-29
Soft-Vu Angiographic Catheter Soft-Vu SO1 recalled for manufacturing defect
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1859-2026·2026-04-29
Soft-Vu Angiographic Catheter Recalled for Guidewire Passage Defect
Angiodynamics recalls Soft-Vu Angiographic Catheters with a manufacturing defect preventing proper guidewire passage through the catheter hub. The affected devices may not function as intended. No injuries have been reported.
Product
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2026·2026-04-29
Soft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall
Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2026·2026-04-29
Angiodynamics Soft-Vu Angiographic Catheter Kumpe Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2026·2026-04-29
Angiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
Angiodynamics is recalling specific lots of Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2026·2026-04-29
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2026·2026-04-29
Soft-Vu Angiographic Catheter Headhunter recalled due to manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided devices because a manufacturing defect may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2026·2026-04-29
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided recalled for manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The defect affects 1,550 units distributed worldwide.
Product
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1856-2026·2026-04-29
Soft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub's inner diameter.
Product
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1860-2026·2026-04-29
Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.
Product
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2026·2026-04-29
AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2026·2026-04-29
Soft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2026·2026-04-29
AccuVu Angiographic Catheter recalled for guidewire passage defect
Angiodynamics is recalling the AccuVu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a properly sized guidewire from passing through the catheter hub's inner diameter.
Product
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2026·2026-04-29
Soft-Vu Angiographic Catheter Omni Flush Non-Braided Defect Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2026·2026-04-29
AccuVu Angiographic Catheter Manufacturing Defect Recall Worldwide
Angiodynamics is recalling AccuVu Angiographic Catheters worldwide due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
Product
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2026·2026-04-29
AccuVu Angiographic Catheter recall due to manufacturing defect
Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1866-2026·2026-04-29
Angiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1863-2026·2026-04-29
Soft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent the guidewire from passing through the catheter hub. The defect affects 1,030 units distributed worldwide.
Product
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1865-2026·2026-04-29
Soft-Vu Angiographic Catheter Cobra Non-Braided recalled by Angiodynamics
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1391-2025·2025-03-26
IsoLoc Prostate Treatment Balloon Devices Recalled for Incorrect Fill Volume Labeling
Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.
Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0770-2025·2025-01-08
Auryon Laser Atherectomy System Recalled for Activation Failure
Angiodynamics is recalling 138 units of the Auryon atherectomy laser system due to potential failure to advance to activation mode during use. This malfunction could cause procedural delays or interruptions.
Product
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2454-2024·2024-08-07
SOFT-VU KUMPE Catheters Recalled for Mislabeled Inner Pouch
Angiodynamics is recalling SOFT-VU KUMPE 5F X 65CM angiographic catheters (595 boxes nationwide) because inner pouch labels may show information for a different catheter model while shelf-box labels are correct.
Product
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2453-2024·2024-08-07
SOFT-VU KUMPE Diagnostic Catheter Recalled for Mislabeled Inner Pouch
Angiodynamics recalls SOFT-VU KUMPE diagnostic catheters because inner pouch labels may show incorrect catheter length information, while the outer box label is accurate. 519 boxes distributed nationwide.
Product
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2267-2024·2024-07-10
Prostate Treatment Balloons Recalled Due to Fill Volume Mislabeling
Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).
Product
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Category
Medical Device
Distribution
Distributed nationwide