PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF...
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Z-0119-2026October 15, 2025Allentown, PA
B BRAUN MEDICAL INC
Class IIOngoing
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17...
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Z-0115-2026October 15, 2025Allentown, PA
B BRAUN MEDICAL INC
Class IIOngoing
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Pro...
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Z-0118-2026October 15, 2025Allentown, PA
Bard Peripheral Vascular Inc
Class IIOngoing
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop...
Reason: Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Abla...
Z-2638-2025October 8, 2025Tempe, AZ
Medline Industries, LP
Class IOngoing
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surface...
Z-2613-2025October 8, 2025Northfield, IL
Medline Industries, LP
Class IOngoing
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart...
Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surface...
Z-2614-2025October 8, 2025Northfield, IL
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, i...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0022-2026October 8, 2025Waterbury, CT
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includin...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0018-2026October 8, 2025Waterbury, CT
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0025-2026October 8, 2025Waterbury, CT
Medline Industries, LP
Class IOngoing
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surface...
Z-2611-2025October 8, 2025Northfield, IL
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includin...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0020-2026October 8, 2025Waterbury, CT
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, inclu...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0019-2026October 8, 2025Waterbury, CT
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0024-2026October 8, 2025Waterbury, CT
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includin...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0021-2026October 8, 2025Waterbury, CT
Medline Industries, LP
Class IOngoing
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Reason: The kits contain certain lots of cannula products where the catheter may not retain its shape.
Z-2670-2025October 8, 2025Northfield, IL
Medline Industries, LP
Class IOngoing
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH ...
Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surface...
Z-2612-2025October 8, 2025Northfield, IL
Northeast Scientific Inc.
Class IIOngoing
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including...
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surface...
Reason: The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Z-2618-2025October 1, 2025Marlborough, MA
C.R. Bard Inc
Class IIOngoing
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone...
Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone...
Z-2591-2025September 24, 2025Covington, GA
C.R. Bard Inc
Class IIOngoing
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone...
Z-2590-2025September 24, 2025Covington, GA
Boston Scientific Corporation
Class IIOngoing
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determine...
Z-2534-2025September 17, 2025Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardi...
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determine...
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determine...