Calendar

Week of Sep 29, 2025

Oct 1, 2025device recall336d agoAbiomed, Inc. device recall (Cls I)Abion Inc

Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432. — Reason: Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). — Status: Ongoing

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Oct 1, 2025device recall336d agoBeckman Coulter, Inc. device recall (Cls II)

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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 recall336d 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, 2025grant336d 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