Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard recall — FDA Z-0197-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
October 2025 recalls — page 9
These records include useful source details for the selected month.
Medical DeviceOct 22, 2025
Baxter Healthcare CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves recall — FDA Z-0189-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing recall — FDA Z-0203-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
American Contract Systems Medical convenience kits IHDC30R D AND C PACK recall — FDA Z-0187-2026
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceOct 22, 2025
Boston Scientific Model Number L221 PROPONENT DR EL Pacemaker recall — FDA Z-0090-2026
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
ARVIS recall — FDA Z-0145-2026
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Class IIFDA: OngoingKico Knee Innovation Company
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code recall — FDA Z-0204-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Boston Scientific Model Number U228, VISIONIST CRT-P EL MRI recall — FDA Z-0105-2026
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
Boston Scientific PROPONENT SR SL (Model L200) recall — FDA Z-0085-2026
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK recall — FDA Z-0202-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Branding is not applied to this product. DVI display cables recall — FDA Z-0169-2026
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by…
Class IIFDA: OngoingSpacelabs Healthcare, Inc.
Medical DeviceOct 22, 2025
Percussionaire Phasitron 5, IPV In-Line Valve recall — FDA Z-0031-2026
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high…
Class IFDA: OngoingPercussionaire Corporation
Medical DeviceOct 22, 2025
Boston Scientific Model Number U226, VISIONIST CRT-P EL recall — FDA Z-0104-2026
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
American Contract Systems Medical convenience kits Item number/ Product description AHLD15X recall — FDA Z-0173-2026
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceOct 22, 2025
Boston Scientific Model Number L209 PROPONENT DR (VDD) SL Pacemaker recall — FDA Z-0087-2026
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK recall — FDA Z-0193-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part recall — FDA Z-0148-2026
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Class IIFDA: OngoingBioPro, Inc.
Medical DeviceOct 22, 2025
Philips Cardiac Workstation 5000 recall — FDA Z-0165-2026
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Class IIFDA: OngoingPhilips North America
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard recall — FDA Z-0198-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
American Contract Systems Medical convenience kits Item Number/Description BUCY78E CYSTO recall — FDA Z-0174-2026
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceOct 22, 2025
American Contract Systems Medical convenience kits Item Number/Description BFCT04X CATARACT recall — FDA Z-0185-2026
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceOct 22, 2025
Boston Scientific Model Number L101, ESSENTIO DR SL Pacemaker recall — FDA Z-0093-2026
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM recall — FDA Z-0150-2026
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Class IIFDA: OngoingBioPro, Inc.
Medical DeviceOct 22, 2025
Boston Scientific Model Number L231, PROPONENT DR EL MRI Pacemaker recall — FDA Z-0091-2026
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Class IFDA: OngoingBoston Scientific Corporation
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.