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-2157-2026May 20, 2026Morrisville, NC
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2186-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
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 ...
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-2159-2026May 20, 2026Morrisville, NC
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2191-2026May 20, 2026Tempe, AZ
Integra LifeSciences Corp. (NeuroSciences)
Class IIOngoing
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diver...
Reason: Out-of-specification endotoxin result that did not meet the acceptance criteria.
Z-2173-2026May 20, 2026Princeton, NJ
Stryker Sustainability Solutions
Class IIOngoing
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2183-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2190-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2196-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2179-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2194-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2193-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2184-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2175-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2188-2026May 20, 2026Tempe, AZ
Stryker Sustainability Solutions
Class IIOngoing
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Z-2197-2026May 20, 2026Tempe, AZ
Cook Incorporated
Class IOngoing
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials a...
Reason: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio...
Z-1934-2026May 13, 2026Bloomington, IN
Cook Incorporated
Class IOngoing
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiogra...
Reason: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio...
Z-1935-2026May 13, 2026Bloomington, IN
Medline Industries, LP
Class IIOngoing
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Reason: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio...
Z-1936-2026May 13, 2026Bloomington, IN
Medtronic, Inc.
Class IIOngoing
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Reason: ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) ...
Z-1948-2026May 6, 2026Mounds View, MN
Merit Medical Systems, Inc.
Class IIOngoing
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Reason: catheter may experience resistance when being advanced over the guidewire