Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1865-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1866-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1867-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1868-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1869-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1870-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1871-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1872-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1873-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1874-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Root cause: Nonconforming Material/Component
Recalling firm: Angiodynamics, Inc.Type: Catheter, Intravascular, DiagnosticDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.Recall #Z-1875-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
JUDKINS PACK DYNJ51126
ANGIO PACK DYNJ32555C, DYNJ66631
ANGIO TRAY DYNJ46153B
ANGIOGRAPHY PACK DYNJ26855F
ANGIOGRAPHY PACK-M-LF DYNJ24530I
ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D
CATH LAB ANGIO PACK-LF DYNJ0545064X
CATH LAB PACK DYNJ39057C
FEMORAL ANGIOGRAPY SET UP DYNJ61015B
RAD-ANGIO PACK DYNJ47710C
SURGERY ANGIO PACK-LF PHS677784013A
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Angiography/Angioplasty KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1876-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ADULT CATH PACK-LF
DYNJ38395G
ANGIO DRAPE PACK (ADLUG)642-LF
DYNJ47665F
DYNJ47665G
ANGIO KIT PACK
DYNJ83746
DYNJ83746A
ANGIO PACK
DYNJ30565G
DYNJ51239C
DYNJ66631A
DYNJ69200A
DYNJ88276
ANGIO PHC
DYNJ37485D
ANGIO TRAY 116118
DYNJ37724K
ANGIO TRAY NO LIDO
DYNJ85557
DYNJ85557B
ANGIOGRAM-30852
DYNJVB91148A
ANGIOGRAPHY DRAPE PACK-LF
DYNJ0373221P
ANGIOGRAPHY PACK
DYNJ17218R
DYNJ44293F
DYNJ44293G
DYNJ44293J
DYNJ83516
ANGIOGRAPHY PACK-LF
DYNJ0854485X
ARTERIOGRAM
DYNJ28082I
BASIC HEART CATH PACK
DYNJVB1075B
CARDIAC CATH
DYNJ910293
CARDIAC CATH PACK
DYNJ68653B
DYNJ68653C
CARDIAC CATH PACK-LF
DYNJ85258
CATH LAB (EP) PACK
DYNJ65162B
CATH LAB ANGIO PACK-LF
DYNJ0545064AA
CATH LAB ANGIO TRAY
DYNJ83506A
CATH LAB PACK
DYNJ66366D
DYNJ66366F
DYNJT2202U
CATH LAB PROCEDURE PK
DYNJ57723C
CATH LAB TRAY
DYNJ37389P
DYNJ37389Q
CATH PACK
DYNJ62595C
DYNJ62595D
DYNJ69997A
HEART CATH PACK
DYNJ85783
HEART CATH-SFMC
DYNJ82434
INTERVENTIONAL PACK
DYNJ56666D
INTERVENTIONAL PACK-LF
DYNJ37211J
INTERVENTIONAL RADIOLOGY PK-LF
DYNJ0516014AI
IR PACK
DYNJ36752B
JUDKINS PACK
DYNJ51126C
M&E ANGIOGRAPHY PK
DYNJ83812
NEURO ANGIO PACK
DYNJ51697C
NEUROLOGICAL CATH PACK
DYNJ63434D
OR HYBRID-MRMC
DYNJ907758C
PTCA PACK
DYNJ55359C
DYNJ55359D
RADIOLOGY ANGIO MAJOR PACK
DYNJ62858C
SURGERY ANGIO PACK-LF
PHS677784013B
ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J
ANGIO IR PACK DYNJ31196G
ANGIO PACK DYNJ30565F, DYNJ69200
ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L
ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I
BGMC CARDIAC CATH PACK-LF DYNJ0664960D
CARDIAC CATH DYNJ59898B
CARDIAC CATH PACK DYNJ68653A, DYNJ69150A
CATH LAB ANGIO PACK-LF DYNJ0545064Y
CATH LAB PACK DYNJ28428F, DYNJ80457
CATH LAB-LF DYNJ51423F
CATH PACK DYNJ62595B, DYNJ62983A
CATH PROCEDURAL TRAY DYNJ43580D
GENERAL ANGIO PACK DYNJ57760C
HEART CATH PACK DYNJ69318
HEART CATH TRAY DYNJ53251J, DYNJ81557
IR PACK DYNJ65312
MAIN OR CATH LAB DYNJ61373A
M CARDIAC CATH DYNJ58339A
N CATH PACK NG140A
OR RADIOLOGY PACK DYNJ62747
RADIOLOGY PACK DYNJ42633C
R ANGIO PACK DYNJ36338C
SPECIAL TRAY DYNJ65756A
TAVR PACK DYNJ69246
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LP
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
TAVR PACK DYNJ69246B
ABDOMINAL VASCULAR-LF DYNJ905291D
ANGIOGRAPHIC PACK DYNJ86769
AORTAGRAM PACK DYNJ26783D
AV FISTULA PACK CHS-LF DYNJ35615G
AV SHUNT PACK-LF DYNJ0842516G
CATHETER PACK DYNJ61926
EP DRAPE PACK-LF DYNJ47645C
EP PACK DYNJ47782G
EPS ACCESSORY PACK DYNJT2201S
H CLINIC VASCULAR PK DYNJ33415A
HEART FAILURE PACK DYNJ64877B
HYBRID PACK DYNJ65925D
INTERVENTIONAL RAD PACK DYNJ44100M
INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG
MV-PACEMAKER PACK-LF DYNJ41556F
NEURO RADIOLOGY RICHMOND DYNJ68365D
OR HYBRID-M DYNJ907758D, DYNJ907758F
PACEMAKER DYNJ907960C
PACEMAKER PACK DYNJ42557B
DYNJ61411
DYNJ61411A
DYNJ61411B
DYNJ80160
PACER PACK DYNJ40952B
PERIPHERAL ARTERIOGRAM RAD DYNJ61383B
RADIOLOGY PACK DYNJ54762D
TAVR PACK DYNJ55338B
DYNJ69246A
VASCULAR ACCESS TRAY DYNJ52606F
VASCULAR TRAY DYNJ49802C
VEIN PACK DYNJ57512
DYNJ58063
DYNJ84953
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1878-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BIOPSY PACK DYNJ38587A, DYNJ38587B
BIOPSY/DRAINAGE TRAY-LF DYNJ30078D
W LINQ PACK DYNJ59108B
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Ct Biopsy TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1879-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
MINOR ENT SINUS PACK-LF
DYNJ0101278F
DYNJ0101278G
DYNJ0101278I
SINUS PACK DYNJ56262
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Ear, Nose, And Throat Surgical TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1880-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BARIATRIC DYNJ905153M, DYNJ905153N
GENERAL LAPAROSCOPY PACK DYNJ81602
LAPAROSCOPY DYNJ905157K, DYNJ905157L
LAPAROTOMY PACK DYNJ46675G
MAJOR LITHOTOMY PACK DYNJ81607
MAJOR PLUS PACK DYNJ905160O
MINOR GENERAL PACK DYNJ81599
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Laparoscopy KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1881-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FACE/RHINOPLASTY PACK DYNJ80343C
PLASTIC HEAD-NECK PACK DYNJ86639
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Plastic Surgery And Accessories KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1882-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BASIC CL PACK-LF DYNJ87052
BASIC PACK DYNJ83976
BASIC SET UP PACK DYNJ80700
CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B
CSTM ANGIO KIT - S VASC1109
CV PACK DYNJ46301C
DR F PACK DYNJ41253B
ENSEMBLE HEMORROIDES DYNJ56311A
G TAVR PACK DYNJ61006
IR MINOR PACK DYNJ44139C
MAJOR PLUS PACK DYNJ905160N
MAXIMUM BARRIER BUNDLE PACK DYNJ35216C
PCI PACK TBRHSC-LF DYNJ41941D
PERC PACK-LF DYNJ0774759P
PERIPHERAL ANGIOGRAPHY PK DYNJ42094B
PROCEDURE PACK DYNJ55063B
PTCA PACK DYNJ55359B
ROBOTIC PACK DYNJ908706C
SPECIAL PROCEDURES TRAY DYNJ41174A
SYRINGE WIRE KIT SANFORD SAMPC0644
WPH EP PACK DYNJ62745
X-RAY PACK DYNJ44295G
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1883-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ANGIO KIT PACK DYNJ50783B
ANGIO PHC DYNJ37485C
C.I.C.N. ANGIO PACK DYNJ53064B
FHT P NEURO PACK DYNJ39931D
NEURO ARTERIOGRAM PACK-LF DYNJ0948060F
NEURO KIT NAM0003
NEURO PACK DYNJ61542D
NEURO RADIOLOGY PACK DYNJ59903B
NEURO TRAY DYNJ84872A
PK, CATH LAB-ANGIO DYNJ44027F
QVH IR NEURO PACK DYNJ62176
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Neurological TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1884-2026