The Recall Desk

Hazard

Inadequate Instructions recalls

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

What the numbers show

Total
25
Critical
0
Severe
4
Most recent
2026-03-18

Of the 25 inadequate instructions recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (16%) 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 inadequate instructions 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 25

  • SevereFDA (Devices)·Z-1547-2026·2026-03-18

    TRUE METRIX AIR manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX AIR blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1546-2026·2026-03-18

    TRUE METRIX PRO manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX PRO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE MET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1548-2026·2026-03-18

    TRUE METRIX GO manuals recalled as Class I over E-5 error guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX GO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1545-2026·2026-03-18

    TRUE METRIX manuals recalled as Class I over E-5 error code guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2025·2025-01-15

    Smaxel Fractional CO2 Laser recalled for missing safety label and instructions

    IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.

    Product
    Smaxel Fractional CO2 Laser, a Class IV medical laser system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2024·2024-01-17

    Olympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations

    Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.

    Product
    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2024·2023-12-13

    HeartWare HVAD Ventricular Assist Device Documentation Update

    HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.

    Product
    STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0479-2024·2023-12-13

    HeartWare HVAD Implant Kit Instructional Update for Fault Alarms

    The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.

    Product
    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0315-2024·2023-11-22

    Cardiovascular Convenience Kit Recalled for Inadequate Chest Drain Instructions

    ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.

    Product
    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0316-2024·2023-11-22

    Ocean Chest Drains Recalled for Inadequate Assembly Instructions

    Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.

    Product
    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0318-2024·2023-11-22

    Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions

    Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.

    Product
    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions

    Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2611-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety

    Tytek Medical is updating instructions and visual guidance for its tension pneumothorax kit to clarify needle decompression risks and proper placement. The update affects 4,400 units distributed in the US and international locations.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1981-2023·2023-06-28

    KARL STORZ sterilization trays recalled for inadequate model-specific instructions

    FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.

    Product
    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2023·2023-06-28

    Karl Storz Sterilization Trays Recalled Due to Inadequate Instructions

    Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.

    Product
    Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2023·2023-05-24

    DuraLife Breathing Circuit Extension Tube Recall Due to Inadequate Sterilization Instructions

    Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.

    Product
    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2023·2023-04-05

    Express Mini 500 Chest Drain Recalled for Inadequate Instructions

    The Express Mini 500 Dry Seal Chest Drain has been recalled because its instructions do not adequately warn against draining it for continued use or using it outside healthcare settings. Approximately 8,184 cases were distributed worldwide.

    Product
    Express Mini 500 Dry Seal Chest Drain, Part Number 16400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2022·2021-12-01

    Ocean Water Seal Chest Drain Recalled for Inadequate Setup Instructions

    Atrium Medical is recalling 87,972 Ocean Water Seal Chest Drains due to inadequate setup instructions that may result in treatment delays and risk of patient harm.

    Product
    The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chambe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit withdrawn for labeling and instruction improvements

    Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2371-2021·2021-09-08

    Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2373-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit Withdrawn for Labeling Enhancements

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2222-2021·2021-08-18

    Stryker Electric Hospital Beds Recalled for Unintended Home Use

    Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.

    Product
    Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0041-2020·2019-10-16

    Giraffe Omnibed Infant Incubator Recalled for Inadequate Cleaning Instructions

    Ohmeda Medical is recalling Giraffe Omnibed infant incubators because cleaning guidelines failed to prevent debris buildup, creating a potential infection risk.

    Product
    Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same tim
    Category
    Medical Device
    Distribution
    Distributed nationwide