Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 25, 2026
Medline Kits:
1) ARTHROGRAM TRAY, Model Number: DYNJ07425;
2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I
3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A
4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B
5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A
6) NEURO CTM IR PACK, Model Number: DYNJ87817
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Neurological TrayDistribution: US Nationwide distribution.Recall #Z-1844-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 25, 2026
Medline Kits:
1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Labor And Delivery KitDistribution: US Nationwide distribution.Recall #Z-1845-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 25, 2026
Medline Kits:
1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution.Recall #Z-1846-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 25, 2026
Medline Kits:
1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C;
2) SLING PACK, Model Number: DYNJ62849B
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Hysterectomy KitDistribution: US Nationwide distribution.Recall #Z-1847-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 25, 2026
Medline Kits:
1) D AND C PACK, Model Number: DYNJ41254B
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Obstetrical KitDistribution: US Nationwide distribution.Recall #Z-1848-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 25, 2026
Medline Kits:
1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F;
2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D
3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A
4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A
5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A
6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A
7) SPINE PACK HC, Model Number: DYNJ84272
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US Nationwide distribution.Recall #Z-1849-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 25, 2026
Medline Kits:
1) ARTHROSCOPY PACK, Model Number: DYNJ82440
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Arthrogram TrayDistribution: US Nationwide distribution.Recall #Z-1850-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Reason: Potential for detachment of a distal tip component of the device during use.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.Recall #Z-1851-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Reason: Potential for detachment of a distal tip component of the device during use.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.Recall #Z-1852-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Reason: Potential for detachment of a distal tip component of the device during use.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.Recall #Z-1853-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Reason: Potential for detachment of a distal tip component of the device during use.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.Recall #Z-1854-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1856-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1857-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1858-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1859-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1860-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1861-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1862-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1863-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 3, 2026
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;
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-1864-2026