The Recall Desk

Hazard

Documentation Error recalls

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

What the numbers show

Total
426
Critical
0
Severe
0
Most recent
2026-09-02

Of the 426 documentation error 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 error 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.

51–75 of 426

  • LowFDA (Devices)·Z-1893-2020·2020-05-13

    Abbott Recalls Architect C Peptide Reagents Due to Licensing Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Reagents in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1762-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Missing Compatibility Data

    Olympus Corporation of the Americas is recalling 265 Pleuravideoscope Model LTF-160 units because data validating compatibility with certain endo-therapy devices was missing.

    Product
    Olympus Pleuravideoscope, Model LTF-160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1763-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Compatibility Data Gaps

    Olympus is recalling 265 Pleuravideoscope units because data validating compatibility with certain endo-therapy devices was missing. Updated manuals are being provided.

    Product
    Olympus Pleuravideoscope, Model LTF-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error

    Life Technologies is recalling 66 units of the Oncomine Dx Target Test RNA Control because the expiration date was extended prior to regulatory clearance.

    Product
    Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1694-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2020·2020-04-08

    Trilliant Surgical Gridlock Ankle Plating System Instructions for Use Recalled

    Trilliant Surgical LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Gridlock Ankle Plating System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1609-2020·2020-04-08

    Trilliant Surgical Gridlock Plating System Instructions for Use Recall

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the Gridlock Plating System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1610-2020·2020-04-08

    Trilliant Surgical Recalls Hammertoe Implant Instructions for Use

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for its Two-Step Hammertoe Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1611-2020·2020-04-08

    Trilliant Surgical 3S Hemi Toe Implant Instructions for Use Recall

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the 3S Hemi Toe Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1614-2020·2020-04-08

    Trilliant Surgical Small Joint Reaming System Instructions for Use Recall

    Trilliant Surgical LLC is recalling Instructions for Use and Cleaning Protocols for the Small Joint Reaming System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1612-2020·2020-04-08

    Trilliant Surgical Recalls Instructions for Use for Cannulated Screw Systems

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for two cannulated screw systems to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the labe
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1616-2020·2020-04-08

    Philips Recalls MRI Patient Monitoring Systems Due to Incorrect Calibration Instructions

    Philips is recalling 2,214 MRI Patient Monitoring Systems because the instructions for oxygen sensor calibration are incorrect for specific software versions.

    Product
    Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1606-2020·2020-04-08

    Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Screw Systems to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1605-2020·2020-04-08

    Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Cannulated Screw Systems to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant S
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1608-2020·2020-04-08

    Trilliant Surgical Disco Subtalar Implant Instructions for Use Recall

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Disco Subtalar Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1607-2020·2020-04-08

    Trilliant Surgical Twist Sublatar Implant System Instructions for Use Recall

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Twist Sublatar Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Devices)·Z-1259-2020·2020-02-26

    Advanced Bionics Cochlear Implant Electrode Recalled for Documentation Error

    Advanced Bionics is recalling four HiResolution Bionic Ear System electrodes in Japan because three materials were omitted from the approved bio-compatibility list.

    Product
    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0647-2020·2019-12-18

    Integra CUSA Clarity System Recall for Sterilization Tray Drying Time Error

    Integra LifeSciences is recalling the C7000 CUSA Clarity System because the Polish OPS Manual incorrectly states the minimum drying time for the 36 kHz Sterilization Tray.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0648-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Sterilization Tray

    Integra LifeSciences is recalling the C7000 CUSA Clarity 36 kHz Sterilization Tray because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0650-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity system because the 36 kHz Sterilization Tray fails to meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0618-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0653-2020·2019-12-18

    Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0643-2020·2019-12-18

    Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error

    Integra LifeSciences is recalling the C7000 CUSA Clarity system because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0616-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states