The Recall Desk

Hazard

Instructions For Use recalls

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

What the numbers show

Total
26
Critical
23
Severe
0
Most recent
2026-02-04

Of the 26 instructions for use recalls we have scored against our rubric, 23 (88%) 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 instructions for use 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 26

  • HighFDA (Devices)·Z-1203-2026·2026-02-04

    Chest drainage units recalled to limit their use to adults

    Cardinal Health is updating the instructions for use on 1,169,726 chest drainage units to clarify that the intended patient population is adults 18 years and older.

    Product
    Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1048-2026·2026-01-21

    Infusion system software recalled to emphasize instructions in the manual

    Fresenius Kabi is recalling 30 units of Ivenix Infusion System LVP software to emphasize the instructions for LVP duration programming set out in the IFU.

    Product
    Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0230-2026·2025-10-29

    Foot plating systems recalled to remove a sterilization option from instructions

    CPM Medical Consultants is updating the Fuse ULTRA Foot Plating System instructions for use to remove a sterilization option that does not apply in the United States.

    Product
    Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS218150, OS292110, OS292120, OS292160, OS292200, OS200516, O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0051-2026·2025-10-22

    BF-1TQ180 bronchovideoscopes recalled for updated therapy equipment use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1TQ180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0058-2026·2025-10-22

    BF-P60 bronchofiberscopes recalled for updated instructions on laser and coagulation use

    Olympus is recalling OES Bronchofiberscope BF Type P60 units for additional instructions-for-use updates clarifying safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0062-2026·2025-10-22

    BF-Q180-AC bronchovideoscopes recalled for updated laser and coagulation use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180-AC units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0050-2026·2025-10-22

    BF-1TQ170 bronchovideoscopes recalled for updated instructions on laser use

    Olympus is recalling Bronchovideoscope BF-1TQ170 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0063-2026·2025-10-22

    BF-Q190 bronchovideoscopes recalled for clarified laser and coagulation instructions

    Olympus is recalling EVIS EXERA III Bronchovideoscope BF-Q190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0056-2026·2025-10-22

    BF-P180 bronchovideoscopes recalled for updated therapy equipment use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type P180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0061-2026·2025-10-22

    BF-Q180 bronchovideoscopes recalled for updated laser and coagulation instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0057-2026·2025-10-22

    BF-P190 bronchovideoscopes recalled for clarified laser and coagulation instructions

    Olympus is recalling EVIS EXERA III Bronchovideoscope BF-P190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0046-2026·2025-10-22

    BF-1T180 bronchovideoscopes recalled for clarified instructions on therapy equipment

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1T180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0067-2026·2025-10-22

    BF-XT40 bronchofiberscopes recalled for updated therapy equipment use instructions

    Olympus is recalling OES Bronchofiberscope BF Type XT40 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0053-2026·2025-10-22

    BF-H190 bronchovideoscopes recalled for updated laser and coagulation use instructions

    Olympus is recalling EVIS EXERA III Bronchovideoscope BF-H190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
    Category
    Medical Device
    Distribution
    Distributed nationwide