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.

76–100 of 426

  • ModerateFDA (Devices)·Z-0652-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    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-0630-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Drying Time Error

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the operator manual lists an incorrect minimum drying time for sterilization trays.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0639-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • LowFDA (Devices)·Z-2493-2019·2019-09-18

    Medtronic Micra Pacemaker Documentation Update for Tether Removal

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

    Product
    Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2133-2019·2019-08-07

    Xhale Assurance Nasal SpO2 Sensor Recall for Missing Instructions

    Xhale Assurance is recalling 701,272 Nasal Alar SpO2 Sensors because the Instructions for Use are missing steps for checking and changing the application site.

    Product
    Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2019·2019-07-31

    Abbott C4 In Vitro Diagnostic Assay Recall for Instruction Manual Updates

    Abbott Laboratories is recalling 8,037 C4 in vitro diagnostic assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2019·2019-07-31

    Abbott Haptoglobin Assay Recalled for Instruction Manual Updates

    Abbott Laboratories is recalling 5,694 Haptoglobin Assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowCPSC·19755·2019-06-28

    Yamaha Recalls Grizzly ATVs and Wolverine X2 ROVs for Incorrect Manuals

    Yamaha is recalling about 1,500 Grizzly ATVs and Wolverine X2 ROVs because the owner's manuals contain information for the wrong models.

    Product
    Yamaha Grizzly ATVs and Wolverine X2 Side-by-Side Vehicles (ROV)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1025-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filters to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the follo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1022-2019·2019-03-27

    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 Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0699-2019·2019-01-16

    Boston Scientific Recalls Blazer Ablation Catheters Due to Resin Changes

    Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.

    Product
    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0701-2019·2019-01-16

    Boston Scientific Recalls IntellaNav Ablation Catheters in Japan

    Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0642-2019·2018-12-26

    Zimmer Biomet Compress System Surgical Technique Correction Recall

    Zimmer Biomet is correcting the surgical technique for the Compress System to update selection criteria for anti-rotation pin placement.

    Product
    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0224-2019·2018-10-31

    Nakanishi SGS Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,662 SGS-E2S surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave parameters.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0225-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 440 Micro Surgery Handpiece SGA units because reprocessing instructions have been updated. Previous operation manuals must be replaced.

    Product
    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0226-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,878 Micro Surgery Handpiece SGA units to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0222-2019·2018-10-31

    Nakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling six SGA-E2G surgical handpieces because reprocessing instructions have been updated to include manual cleaning and specific autoclave parameters.

    Product
    Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0220-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling SGS-E2G surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states