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 (P...
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.
Z-1874-2026April 29, 2026Queensbury, NY
ARROW INTERNATIONAL, LLC
Class IIOngoing
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide pr...
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Z-1915-2026April 29, 2026Morrisville, NC
ARROW INTERNATIONAL, LLC
Class IIOngoing
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Acce...
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
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.
Z-1856-2026April 29, 2026Queensbury, NY
Angiodynamics, Inc.
Class IIOngoing
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 (Pou...
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.
Z-1872-2026April 29, 2026Queensbury, NY
Angiodynamics, Inc.
Class IIOngoing
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 pouche...
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.
Z-1860-2026April 29, 2026Queensbury, NY
ARROW INTERNATIONAL, LLC
Class IIOngoing
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen...
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Z-1917-2026April 29, 2026Morrisville, NC
ARROW INTERNATIONAL, LLC
Class IIOngoing
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Cathe...
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
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.
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.
Z-1864-2026April 29, 2026Queensbury, NY
Gentuity, LLC
Class IIOngoing
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Reason: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This...
Z-1823-2026April 22, 2026Sudbury, MA
Cook Incorporated
Class IIOngoing
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1786-2026April 15, 2026Bloomington, IN
Cook Incorporated
Class IIOngoing
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Num...
Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1783-2026April 15, 2026Bloomington, IN
Cook Incorporated
Class IIOngoing
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1785-2026April 15, 2026Bloomington, IN
Cook Incorporated
Class IIOngoing
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference ...
Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb...
Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb...
Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb...
Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb...
Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb...
Z-1577-2026April 1, 2026South Jordan, UT
Medline Industries, LP
Class IIOngoing
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Reason: Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result ...