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Week of Nov 3, 2025

25

Nov 4, 2025device recall284d agoDatascope Corp. device recall (Cls II)

Cardiosave Rescue. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

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Nov 4, 2025device recall284d agoDatascope Corp. device recall (Cls II)

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

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Nov 5, 2025device recall283d agoCepheid device recall (Cls II)

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. — Reason: Product testing did not meet expected stability criteria. — Status: Ongoing

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Nov 5, 2025device recall283d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall283d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall283d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall283d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall283d agoAccriva Diagnostics, Inc. device recall (Cls II)Co-Diagnostics, Inc.

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System — Reason: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. — Status: Ongoing

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Nov 5, 2025device recall283d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall283d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 6, 2025device recall282d agoC.R. Bard Inc device recall (Cls II)

BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing

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Nov 6, 2025device recall282d agoPATH device recall (Cls II)PATH

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) — Reason: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome. — Status: Ongoing

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Nov 6, 2025device recall282d agoC.R. Bard Inc device recall (Cls II)

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing

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Nov 6, 2025device recall282d agoC.R. Bard Inc device recall (Cls II)

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing

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Nov 6, 2025device recall282d agoBard Peripheral Vascular Inc device recall (Cls II)

Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, — Reason: Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels. — Status: Ongoing

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Nov 6, 2025device recall282d agoCareFusion 303, Inc. device recall (Cls II)

BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications. — Reason: Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network — Status: Ongoing

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Nov 6, 2025device recall282d agoC.R. Bard Inc device recall (Cls II)

BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing

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Nov 7, 2025device recall281d agoRocket Medical Plc device recall (Cls II)

Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing

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Nov 7, 2025device recall281d agoBeckman Coulter, Inc. device recall (Cls II)

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901 — Reason: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results. — Status: Ongoing

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Nov 7, 2025device recall281d agoRocket Medical Plc device recall (Cls II)

Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing

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Nov 7, 2025device recall281d agoRocket Medical Plc device recall (Cls II)

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing

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Nov 7, 2025device recall281d agoRocket Medical Plc device recall (Cls II)

Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing

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Nov 7, 2025device recall281d agoRocket Medical Plc device recall (Cls II)

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing

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Nov 7, 2025device recall281d agoRocket Medical Plc device recall (Cls II)

Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing

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Nov 7, 2025device recall281d agoIntuitive Surgical, Inc. device recall (Cls II)INTUITIVE SURGICAL INC

Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument — Reason: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction — Status: Ongoing

Week of Nov 10, 2025

25

Nov 10, 2025device recall278d agoBeckman Coulter, Inc. device recall (Cls II)

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent. — Reason: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. — Status: Ongoing

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