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
Monthly breakdown
2025 recalls by month
Select a month to review the recall records reported during that period.
December 2025389 records · 4 categoriesNovember 2025326 records · 4 categoriesOctober 2025455 records · 4 categoriesSeptember 2025285 records · 4 categoriesAugust 2025239 records · 4 categoriesJuly 2025370 records · 4 categoriesJune 2025342 records · 4 categoriesMay 2025258 records · 4 categoriesApril 2025302 records · 4 categoriesMarch 2025259 records · 4 categoriesFebruary 2025260 records · 4 categoriesJanuary 2025354 records · 4 categories
2025 recalls — page 39
Records are ordered by the best available source date.
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
Medical DeviceOct 22, 2025
Ferno-Washington FERNO POWER X2 POWERED AMBULANCE COT recall — FDA Z-0133-2026
The fastening post hardware could loosen allowing the fastening post to detach from the cot
Class IIFDA: OngoingFerno-Washington Inc.
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter recall — FDA Z-0195-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Boston Scientific Model Number U128, VALITUDE CRT-P EL MRI recall — FDA Z-0102-2026
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
GE Medical Systems LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7. recall — FDA Z-0156-2026
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceOct 22, 2025
American Contract Systems Medical convenience kits Item Number/Description HSAN63N ANGIO recall — FDA Z-0180-2026
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.
About the 2025 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.