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.

376–400 of 426

  • ModerateFDA (Devices)·Z-1972-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides

    Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from instructions.

    Product
    IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2014·2014-07-09

    Intuitive Surgical Recalls Vessel Sealer Addendum for da Vinci Systems

    Intuitive Surgical is recalling Vessel Sealer Addendum software for da Vinci surgical systems to update user manuals and remove the Emergency Grip Release Wrench.

    Product
    Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1975-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides

    Intuitive Surgical is recalling Natural Rubber Latex Quick Reference Guides for the da Vinci Surgical System to update documentation and remove a specific wrench part.

    Product
    Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1973-2014·2014-07-09

    Intuitive Surgical Recalls Cautery QRG for da Vinci Surgical Systems

    Intuitive Surgical is recalling Cautery Quick Reference Guides for da Vinci systems to update documentation and remove a specific wrench part.

    Product
    Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1966-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Vision Troubleshooting Guides

    Intuitive Surgical is recalling Vision Troubleshooting Guides for the da Vinci Surgical System to remove references to the Emergency Grip Release Wrench.

    Product
    Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Endowrist Instrument Manuals

    Intuitive Surgical is recalling Endowrist Instrument and Accessory Manuals for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.

    Product
    Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2014·2014-07-09

    Intuitive Surgical Recalls Vessel Sealer QRG for da Vinci Systems

    Intuitive Surgical is recalling Vessel Sealer QRGs for da Vinci systems to remove the Emergency Grip Release Wrench from documentation.

    Product
    Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Manuals Due to Wrench Removal

    Intuitive Surgical is recalling da Vinci Surgical System manuals to remove the Emergency Grip Release Wrench from the documentation.

    Product
    Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1949-2014·2014-07-09

    DeVilbiss DV5x Series CPAP Units Recalled for Missing Serial Numbers

    DeVilbiss Healthcare LLC is recalling 1,809 DV5x Series CPAP units because they were shipped without programmed serial numbers, displaying 'RUN-TEST' on the screen.

    Product
    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2014·2014-07-02

    ProBeam Proton Therapy System Recalled for Treatment History Data Loss

    Varian Medical Systems is recalling ProBeam Proton Therapy Systems because the Treatment Control and Monitoring application may fail to send treatment history records to the ARIA database.

    Product
    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1680-2014·2014-06-11

    Bacterin Elutia Wound Drains Recalled for Missing Dose Audits

    Bacterin International is recalling Elutia Hubless Coated Silicone Surgical Wound Drains because quarterly dose audits were omitted. The products were appropriately sterilized.

    Product
    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1631-2014·2014-05-28

    SCM True Air Technologies Recalls ECATS E 850 Bariatric Beds

    SCM True Air Technologies is recalling 48 ECATS E 850 Bariatric Beds due to manufacturing documentation and vendor approval failures.

    Product
    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2014·2014-05-21

    Greatbatch Recalls Coaxial Micro-Introducer Kits Due to Shelf Life Documentation Issues

    Greatbatch Medical is recalling Coaxial Micro-Introducer Kits because documentation does not support the claimed five-year shelf life.

    Product
    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0708-2014·2014-01-15

    Anspach Recalls Micro Curved Attachments Due to Unclear Directions for Use

    The Anspach Effort, Inc. is recalling MCA Micro Curved Attachments and cutting burrs because the directions for use do not clearly specify intended use for delicate bone in otologic procedures.

    Product
    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2014·2014-01-08

    RTC 25-C Inline Aerosol Tee Adapter Recalled for Incomplete Instructions

    Instrumentation Industries Inc. is recalling 220 units of the RTC 25-C Inline Aerosol Tee Adapter because some packages were shipped with incomplete installation and usage directions due to a printing error.

    Product
    RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0174-2014·2013-11-13

    St. Jude Medical Recalls Ablation Catheters Due to Incorrect Instructions

    St. Jude Medical is recalling 59 ablation catheters shipped with the wrong Instructions for Use (IFU). The recall covers specific batches distributed in six US states.

    Product
    US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maxim
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0110-2014·2013-11-06

    Intuitive Surgical Recalls da Vinci Single Site Instruments for Missing Manual Revisions

    Intuitive Surgical is recalling da Vinci Single Site Bipolar Maryland Forceps and curved needle drivers shipped with incorrect user manuals.

    Product
    Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0111-2014·2013-11-06

    Intuitive Surgical da Vinci Single Site Instruments Recalled for Missing Manual Revisions

    Intuitive Surgical is recalling specific da Vinci Single Site instruments because they were shipped without the correct user manual revision, which contains necessary instructions, warnings, and precautions.

    Product
    Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recall for Incomplete Operator Manual

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump reactions during specific alarm conditions.

    Product
    Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2013·2013-08-07

    Picis ED Pulsecheck Software Recall for Missing Prescription Notes

    Picis Inc. is recalling ED Pulsecheck software versions 5.2 and 5.3 because prescription notes are not printed to the prescription or patient chart.

    Product
    Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1796-2013·2013-07-31

    Haemonetics Recalls TEG 5000 Analyzers Due to Manual Errors

    Haemonetics is recalling 1,590 TEG 5000 Thromboelastograph Coagulation Analyzers because the user manual incorrectly included Research Use Only parameters.

    Product
    TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1448-2013·2013-06-26

    Philips Diagnost Stationary Radiographic System Recalled for Table Height Non-Compliance

    Philips Healthcare Inc. is recalling 101 units of Diagnost Stationary Radiographic Systems because installation records show table height measurements out of specification.

    Product
    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins and Sterilization Trays for Missing Instructions

    Spinal Solutions, LLC is recalling 56 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions

    Spinal Solutions is recalling 35 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2013·2013-06-05

    Spinal Solutions Recalls 60 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 72 units of 60 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
    Category
    Medical Device
    Distribution
    Distributed nationwide