Medical DeviceDec 10, 2025
Philips IntelliVue MP70. Product Number: M8007A recall — FDA Z-0856-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
December 2025 recalls — page 8
These records include useful source details for the selected month.
Medical DeviceDec 10, 2025
Philips IntelliVue Patient Monitor MX450 recall — FDA Z-0863-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue Patient Monitor MX750 recall — FDA Z-0868-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue Patient Monitor MX550 recall — FDA Z-0865-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Siemens Medical Solutions USA MAMMOMAT Revelation recall — FDA Z-0877-2026
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceDec 10, 2025
Accriva Diagnostics Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR recall — FDA Z-0880-2026
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.
Class IIFDA: OngoingAccriva Diagnostics, Inc.
Medical DeviceDec 10, 2025
Philips IntelliVue Multi-Measurement Module X3 recall — FDA Z-0860-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue Patient Monitor MX400 recall — FDA Z-0862-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Illumina Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument recall — FDA Z-0884-2026
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue,…
Class IIFDA: OngoingIllumina, Inc.
Medical DeviceDec 10, 2025
Philips IntelliVue Patient Monitor MX600 recall — FDA Z-0866-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue MP20. Product Number: M8001A recall — FDA Z-0851-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue MP5. Product Number: M8105A recall — FDA Z-0850-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue MP60. Product Number: M8005A recall — FDA Z-0855-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Enterix InSure ONE Fecal Immunochemical Test recall — FDA Z-0725-2026
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Class IIFDA: OngoingEnterix, Inc.
Medical DeviceDec 10, 2025
Philips IntelliVue Multi Measurement Server X2 recall — FDA Z-0859-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue MP40. Product Number: M8003A recall — FDA Z-0853-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue Patient Monitor MX100 recall — FDA Z-0861-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue MP80. Product Number: M8008A recall — FDA Z-0857-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips IntelliVue MP50. Product Number: M8004A recall — FDA Z-0854-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Philips Incisive CT; Software Version Number: 4.5, 5.0, 5.1 recall — FDA Z-0881-2026
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Fresenius Kabi USA IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet recall — FDA Z-0586-2026
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceDec 10, 2025
Philips IntelliVue MP2. Product Number: M8102A recall — FDA Z-0849-2026
Potential issue where the IntelliVue monitors did not alarm.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 10, 2025
Siemens Medical Solutions USA MAMMOMAT Fusion recall — FDA Z-0879-2026
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceDec 10, 2025
Microbiologics KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus recall — FDA Z-0876-2026
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Class IIFDA: OngoingMicrobiologics Inc.
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.