The Recall Desk

Hazard

Documentation Update recalls

34 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
34
Critical
0
Severe
0
Most recent
2026-04-01

Of the 34 documentation update recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all documentation update recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 34

  • ModerateFDA (Devices)·Z-1645-2026·2026-04-01

    BD Alaris system labeling omits required TLS version for secure Wi-Fi

    CareFusion is recalling the BD Alaris System with Guardrails Suite MX because the product labeling does not indicate which TLS version must be enabled on the hospital network for secure Wi-Fi communication.

    Product
    BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1622-2026·2026-04-01

    Philips Mini Multi TEE transducer labelling updated to define useful life

    Philips is recalling the Mini Multi TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips Mini Multi TEE Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1620-2026·2026-04-01

    Philips L12-5 ultrasound transducer labelling updated to define useful life

    Philips is recalling the L12-5 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips L12-5 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1619-2026·2026-04-01

    Philips C9-4 ultrasound transducer labelling updated to define useful life

    Philips is recalling one C9-4 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips C9-4 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1618-2026·2026-04-01

    Philips 3D6-2 ultrasound transducer labelling updated to define useful life

    Philips is recalling the 3D6-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips 3D6-2 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1624-2026·2026-04-01

    Philips OMNI III TEE transducer labelling updated to define useful life

    Philips is recalling the OMNI III TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips OMNI III TEE Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1627-2026·2026-04-01

    Philips X3-1 ultrasound transducer labelling updated to define useful life

    Philips is recalling the X3-1 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips X3-1 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1625-2026·2026-04-01

    Philips S4-1 ultrasound transducer labelling updated to define useful life

    Philips is recalling the S4-1 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips S4-1 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1626-2026·2026-04-01

    Philips S5-2 ultrasound transducer labelling updated to define useful life

    Philips is recalling one S5-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips S5-2 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1621-2026·2026-04-01

    Philips L17-5 ultrasound transducer labelling updated to define useful life

    Philips is recalling two L17-5 Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips L17-5 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1628-2026·2026-04-01

    Philips X7-2 ultrasound transducer labelling updated to define useful life

    Philips is recalling the X7-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips X7-2 Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1623-2026·2026-04-01

    Philips OMNI II TEE transducer labelling updated to define useful life

    Philips is recalling two OMNI II TEE Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.

    Product
    Philips OMNI II TEE Ultrasound Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1562-2026·2026-03-18

    Chest drainage unit instructions updated to specify adult patient population

    Medline is recalling three surgical kits containing Cardinal Health Aqua-Seal Chest Drainage Units because the instructions for use have been updated to clarify the target patient population as adults.

    Product
    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1487-2026·2026-03-11

    Datascope CS300 balloon pump manual recalled for outdated battery specifications

    Datascope is recalling the CS300 IABP running software version C.01 because the battery runtime and cycle specifications in the device's Instructions for Use need to be updated.

    Product
    CS300 IABP. Software Version CS300 IABP C.01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2026·2026-03-11

    Datascope CS100 balloon pump manual recalled for outdated battery specifications

    Datascope is recalling the CS100 IABP running software version Q.01 because the battery runtime and cycle specifications in the device's Instructions for Use need to be updated.

    Product
    CS100 IABP. Software Version CS100 IABP Q.01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0120-2021·2020-10-28

    Baxter SIGMA Spectrum Infusion Pump IFU Update for Cleaning Practices

    Baxter is updating the Instructions for Use for the SIGMA Spectrum Infusion Pump to clarify safety communication regarding cleaning practices.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1718-2020·2020-04-22

    FDA Recalls Endocuff Vision Colonoscopy Device Due to Labeling Update

    Boddingtons Plastics Ltd is recalling Endocuff Vision models ARV 110, 120, 130, and 140 to update instructions regarding contraindications and potential complications.

    Product
    Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2492-2019·2019-09-18

    Medtronic Micra Pacemaker Documentation Update for Tether Removal

    Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to include specific information on tether removal during implant.

    Product
    Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1023-2019·2019-03-27

    Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates

    Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.

    Product
    Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2018·2018-04-25

    Terumo Sarns TCM Recall for Updated Cooler-Heater Cleaning Instructions

    Terumo is recalling Sarns TCM devices to update cleaning instructions for the cooler-heater component.

    Product
    Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1047-2017·2017-01-25

    Endologix Updates Instructions for Use for AFX Endovascular AAA System

    Endologix is updating the Instructions for Use and making modifications to the AFX Endovascular AAA System. This applies to procedures conducted after October 2015.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1039-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Update

    Endologix is updating the Instructions for Use and implementing modifications to the AFX Endovascular AAA System.

    Product
    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdomi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1037-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Updated

    Endologix updated the Instructions for Use and modified the AFX Endovascular AAA System. The correction applies to procedures conducted after July 2015.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdomin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1054-2017·2017-01-25

    Endologix Updates Instructions for Use for AFX Endovascular AAA System

    Endologix is recalling 17,139 units of the AFX Endovascular AAA System to update the Instructions for Use and implement device modifications.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
    Category
    Medical Device
    Distribution
    0 states