Calendar

Week of Sep 29, 2025

Oct 1, 2025device recall332d agoMedline Industries, LP device recall (Cls II)

Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing

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Oct 1, 2025device recall332d agoQuest International, Inc. device recall (Cls II)QDM International Inc.

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component — Reason: Due to distributing the measles IgG IVD without a premarket approved/cleared. — Status: Ongoing

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Oct 1, 2025device recall332d agoPhilips Medical Systems DMC GmbH device recall (Cls II)

ProxiDiagnost N90; Model Number: 706110; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing

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Oct 1, 2025device recall332d agoMedline Industries, LP device recall (Cls II)

Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing

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Oct 1, 2025device recall332d agoPhilips Medical Systems DMC GmbH device recall (Cls II)

CombiDiagnost R90; Model Number: 709031; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing

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Oct 1, 2025device recall332d agoMedline Industries, LP device recall (Cls II)

Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing

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Oct 1, 2025device recall332d agoMedline Industries, LP device recall (Cls II)

Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing

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Oct 1, 2025device recall332d agoMicrogenics Corporation device recall (Cls II)

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control — Reason: The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays. — Status: Ongoing

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Oct 1, 2025device recall332d agoMedline Industries, LP device recall (Cls II)

Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing

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Oct 1, 2025device recall332d agoENDOMAGNETICS LTD device recall (Cls II)

Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. — Reason: Potential for contamination with cotton fibers. — Status: Ongoing

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Oct 1, 2025device recall332d agoBeckman Coulter, Inc. device recall (Cls II)

Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer — Reason: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results. — Status: Ongoing

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Oct 1, 2025device recall332d agoSiemens Medical Solutions USA, Inc device recall (Cls I)

MAGNETOM Cima.X Upgrade. Model Number: 11689304. — Reason: There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing

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Oct 1, 2025device recall332d agoMedline Industries, LP device recall (Cls II)

Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing

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Oct 1, 2025device recall332d agoPhilips Medical Systems DMC GmbH device recall (Cls II)

DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing

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Oct 1, 2025grant332d agoRLR VA MEDICAL CENTER — Boosting employment to improve health and recovery among Veterans in substanc...

VA grant. PI: Alan Benjamin McGuire

Week of Sep 29, 2025