Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Z-2219-2026May 27, 2026Brooklyn Park, MN
Becton, Dickinson and Company
Class IIOngoing
Swan-Ganz Pacing Catheter, Models: D200F7;
Reason: Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl...
Z-2204-2026May 27, 2026Irvine, CA
Medtronic Perfusion Systems
Class IIOngoing
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Z-2217-2026May 27, 2026Brooklyn Park, MN
Medtronic Perfusion Systems
Class IIOngoing
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Z-2215-2026May 27, 2026Brooklyn Park, MN
Medtronic Perfusion Systems
Class IIOngoing
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Z-2221-2026May 27, 2026Brooklyn Park, MN
Medtronic Perfusion Systems
Class IIOngoing
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Z-2222-2026May 27, 2026Brooklyn Park, MN
Medtronic Perfusion Systems
Class IIOngoing
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Z-2216-2026May 27, 2026Brooklyn Park, MN
Medtronic Perfusion Systems
Class IIOngoing
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Reason: Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl...
Z-2202-2026May 27, 2026Irvine, CA
Becton, Dickinson and Company
Class IIOngoing
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Reason: Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl...
Z-2203-2026May 27, 2026Irvine, CA
Medtronic Perfusion Systems
Class IIOngoing
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Reason: Due to stain present on the surface of affected foley catheters.
Z-2226-2026May 27, 2026Covington, GA
TANGENT ENDOSCOPY, LLC
Class IIOngoing
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Reason: Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Z-2209-2026May 27, 2026Camden, DE
Medtronic Perfusion Systems
Class IIOngoing
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
Reason: Certain lots of product have the potential for a sterile barrier breach.
Z-2220-2026May 27, 2026Brooklyn Park, MN
Stryker Sustainability Solutions
Class IIOngoing
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2199-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2181-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2189-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2198-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2187-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2195-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2176-2026May 20, 2026Tempe, AZ
ARROW INTERNATIONAL, LLC
Class IOngoing
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplici...
Reason: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and ...
Z-2158-2026May 20, 2026Morrisville, NC
Stryker Sustainability Solutions
Class IIOngoing
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2180-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2174-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER