Recalls in Washington (page 3)
4037 recalls.
- MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: C-SECTION PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE DRAPE C-SECTION FEN CLR SCREEN W recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS recall (Medline Industries, LP)
Medical deviceClass IIReported October 28, 2026 · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. - Xact mole marker for mammography Model/Catalog Number: M15RM recall (Solstice Corporation)
Medical deviceClass IIReported October 28, 2026 · The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. - InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT... recall (Medtronic Neuromodulation)
Medical deviceClass IIReported October 28, 2026 · Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may... - InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI... recall (Medtronic Neuromodulation)
Medical deviceClass IIReported October 28, 2026 · Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may... - Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported October 28, 2026 · A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier... - Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number:... recall (restor3d Inc.)
Medical deviceClass IIReported October 28, 2026 · Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIReported October 28, 2026 · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the... - Ion Torrent Genexus Dx with software recall (Life Technologies Holdings Pte Ltd)
Medical deviceClass IIReported October 28, 2026 · DNA or RNA sequencing system software has vulnerabilities. - Techno-Path Multichem AE Unassayed Level 3 recall (TECHNO-PATH MANUFACTURING LTD.)
Medical deviceClass IIReported October 28, 2026 · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material.... - Techno-Path Multichem AE Unassayed Level 2 REF: AE622X recall (TECHNO-PATH MANUFACTURING LTD.)
Medical deviceClass IIReported October 28, 2026 · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material.... - Techno-Path Multichem AE Unassayed Level 1 REF:AE621X recall (TECHNO-PATH MANUFACTURING LTD.)
Medical deviceClass IIReported October 28, 2026 · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material.... - Generic Name: Softmed Breathables Advanced Toric recall (CooperVision, Inc.)
Medical deviceClass IIReported October 28, 2026 · The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product... - CareLink Clinic recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported October 28, 2026 · CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values... - ROTOR ASSY-SW41 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 28, 2026 · Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break... - ROTOR ASSY-SW40 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 28, 2026 · Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a... - Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog... recall (Greiner Bio-One North America, Inc.)
Medical deviceClass IIReported October 28, 2026 · Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+)... - Philips Smart-hopping 2.0 AP 1.4 GHz recall (Philips North America)
Medical deviceClass IIReported October 28, 2026 · Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in... - Think Surgical Square Driver REF: 109126 recall (Think Surgical, Inc.)
Medical deviceClass IIReported October 28, 2026 · Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during... - Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 ... recall (Abbott)
Medical deviceClass IIReported October 28, 2026 · Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI). - V*Home recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - V+ Pro Emergency recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VC recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VC Model Number: PRT-01098-000 recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - V+Pro Model Number: PRT-01185-000 recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VCSN+Pro Model Number: PRT-01184-000 recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VOCSN recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VOCSN Model Number: PRT-01100-000 recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VC+Pro recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VC+Pro Model Number: PRT-00900-001 recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VOCSN+Pro recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - VOCSN+Pro recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported October 28, 2026 · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of... - BAMAMON Recalls LED Projecting Finger Light Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported October 22, 2026 · None reported. - Lithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arm Mountings Due to Risk of Serious Injury from Impact Hazard
Consumer productReported October 22, 2026 · The knuckle of the recalled adjustable tilt arm mountings can fail, allowing the luminaire to fall from the mounting arm, posing a risk of serious injury due... - Costway Recalls Convertible High Chairs Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory Standard for High Chairs
Consumer productReported October 22, 2026 · The convertible high chairs violate the mandatory safety standard for high chairs because they do not contain a passive restraint system and a child can slip... - VQQQ Gas Patio Heaters Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards
Consumer productReported October 22, 2026 · Components on the recalled patio heaters can malfunction, causing gas to be released, posing a risk of serious injury or death from fire and burn hazards. - FoShanShiNanHaiQuNuoAiTongZhuangShangHang Recalls CIYTI Light-Up Princess Costumes Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported October 22, 2026 · The costumes violate the mandatory safety standard for toys because the button cell batteries can be accessed easily by children, posing a deadly ingestion... - The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists recall (Radiometer Medical ApS)
Medical deviceClass IIReported October 21, 2026 · In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood... - Williams Cystoscopic Injection Needles recall (Cook Incorporated)
Medical deviceClass IIReported October 21, 2026 · The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during... - IQ200 SPRINT recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 21, 2026 · The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however... - DxU 840m Iris recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 21, 2026 · The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however... - Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 ... recall (Baxter Healthcare Corporation)
Medical deviceClass IIReported October 21, 2026 · Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift... - Generic Name: BioFire¿ Joint Infection recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported October 21, 2026 · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results - Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel... recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported October 21, 2026 · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results - Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel ... recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported October 21, 2026 · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results - Power F2 Powered Fastening System recall (Ferno-Washington Inc)
Medical deviceClass IIReported October 21, 2026 · Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system... - NaviFlex LW Pusher recall (Boston Scientific Corporation)
Medical deviceClass IIReported October 21, 2026 · Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this... - JenaValve Trilogy Delivery Catheter recall (Jenavalve Technology Inc.)
Medical deviceClass IIReported October 21, 2026 · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. - JenaValve Trilogy Delivery Catheter recall (Jenavalve Technology Inc.)
Medical deviceClass IIReported October 21, 2026 · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.