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Angiodynamics, Inc. FDA Recalls
63 recalls on file across devices, 0 of them Class I and 59 still open. Matched by name to ANGO.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; ProduClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; ProdClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; ProduClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; ProductClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; ProClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401;Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| 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; Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; ProdClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; ProdClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 107Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; ProduClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; ProducClass IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| 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;Class IIMar 3, 2026The affected devices contain a manufacturing defect which ma |
| IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;Class IIFeb 4, 2025Product is mislabeled with the incorrect fill volume. |
| AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100Class IINov 25, 2024Potential for procedural delays or interruptions during use |
| SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701Class IIJun 18, 2024Mislabeled. The shelf-box labeling (unit of sale) is accurat |
| SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702Class IIJun 18, 2024Mislabeled. The shelf-box labeling (unit of sale) is accurat |
| IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100Class IIMay 21, 2024A single batch of ISO-100 IsoLoc Gas-Release Endorectal Ball |
| DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for HemoClass IIMar 18, 2024XXX |
| DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and AClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031Class IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for HemClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for HemodialyClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for HemodialClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for HemodialyClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and ApherClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and AClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Class IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and AClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for HemodialyClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for HemoClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Class IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for HemodialyClass IIMar 18, 2024Tri-Ball Tunneler may contain loosely affixed metal shavings |
| MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into Class IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the Class IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the Class IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vaClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vaClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the Class IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756Class IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into thClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vaClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire intClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the Class IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire intoClass IIJan 30, 2024Non-conformance may prevent the guidewire from passing throu |
| PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx1Class IIDec 18, 2023Rotating adaptor O-ring manufacturing defect impacting seal |
| NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog NumberClass IIMar 2, 2023Not programmed in accordance with specification. The program |
| Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central vClass IISep 20, 2022Printed Instructions for Use (IFU) not shipped with device. |
| VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). FClass IIAug 10, 2022OPS Fiber packaged within specific VenaCure EVLT Procedure K |
| Solero Generator PG, Item No. H78712740000, Catalog No. 12740000Class IIJul 20, 2021Specific serial numbers of the Solero MTA Generator require |
| Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000USClass IIJul 20, 2021Specific serial numbers of the Solero MTA Generator require |
| Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USDClass IIJul 20, 2021Specific serial numbers of the Solero MTA Generator require |
| Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000DClass IIJul 20, 2021Specific serial numbers of the Solero MTA Generator require |