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.

226–250 of 426

  • ModerateFDA (Devices)·Z-1574-2016·2016-05-04

    Synthes Periprosthetic Locking Screw Recalled for Post-Expiration Shipment

    Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws shipped after their expiration date.

    Product
    5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1394-2016·2016-04-20

    Alcon Recalls VERION Reference Units Due to Surgical Plan Errors

    Alcon is voluntarily recalling 97 VERION Reference Units because unplanned arcuate lines may appear on printed or exported surgical plans.

    Product
    VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2016·2016-03-30

    Zimmer Biomet Issues Correction Notice for Instinct Java System Cleaning Instructions

    Zimmer Biomet is issuing a correction notice to provide updated cleaning and disinfecting instructions for the Instinct Java System and Universal Clamp System.

    Product
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1244-2016·2016-03-30

    MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error

    Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1050-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 522 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corre
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-1053-2016·2016-03-16

    GE Medical Systems Recalls CT and PET Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 104 CT and PET/CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuat
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-1052-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Manual Error

    GE Medical Systems is recalling specific CT and PET CT scanners because service manuals contained an incorrect torque value.

    Product
    LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-1048-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Service Manual Error

    GE Medical Systems is recalling 25 CT and PET CT scanner systems because their service manuals contain an incorrect torque value.

    Product
    LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole b
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1032-2016·2016-03-09

    Novadaq PINPOINT Endoscopic Imaging System Recalled for Manual Error

    Novadaq is recalling 110 PINPOINT Endoscopic Fluorescence Imaging Systems because the operator's manual lacks validated sterilization parameters for specific components.

    Product
    PINPOINT Endoscopic Fluorescence Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0779-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions

    Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was omitted from the latest instructions for use.

    Product
    IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0773-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions

    Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was omitted from the instructions for use.

    Product
    IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0774-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions

    Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was missing from the instructions for use.

    Product
    IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or mor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions

    Zimmer Dental Inc is recalling specific Trabecular Metal dental implants because safety information was missing from the instructions for use.

    Product
    IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0775-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Instructions in Manual

    Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because critical safety information was missing from the instruction manual.

    Product
    IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0777-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Instructions

    Zimmer Dental Inc. is recalling specific dental implants because important safety information was missing from the latest instruction manual.

    Product
    IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0782-2016·2016-02-17

    Zimmer Dental Implants Recalled for Missing Instructions in Manual

    Zimmer Dental Inc is recalling specific Trabecular Metal implants because the latest instruction manual omitted critical safety information for certain sizes.

    Product
    IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0784-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions

    Zimmer Dental Inc. is recalling specific dental implants because safety information was missing from the instructions for use.

    Product
    IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0674-2016·2016-01-27

    Valeant SPAG-2 Nebulizer Recalled for Incorrect Serial Labels and Manual Information

    Valeant is recalling 1,178 SPAG-2 nebulizer units because serial ID labels and operation manuals contain incorrect or outdated information.

    Product
    Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0170-2016·2015-11-04

    Varian ARIA Radiation Oncology Software Recall for Printing Anomaly

    Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.

    Product
    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2016·2015-10-28

    Natus neoBLUE 3 Phototherapy System Recalled for Intensity Documentation

    Natus Medical is recalling 4,560 neoBLUE 3 Phototherapy systems because the instruction manuals did not accurately reflect the cleared intensity settings.

    Product
    Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2810-2015·2015-09-30

    Stryker Recalls Trident Hip Implant Components Due to Documentation Error

    Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.

    Product
    Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1305-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 18/1/10 Injection because proper environmental monitoring documentation was missing during production.

    Product
    SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1310-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Due to Sterility Documentation Gaps

    The Apothecary Shoppe is recalling SIU-Tri-Mix vials because documentation for environmental monitoring during production was missing, raising concerns about sterility.

    Product
    SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1291-2015·2015-08-12

    Apothecary Shoppe Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIH-Testosterone Cypionate Injection because proper environmental monitoring documentation is missing, raising concerns about sterility.

    Product
    SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34
    Category
    Drug
    Distribution
    1 state