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.

26–50 of 426

  • HighFDA (Devices)·Z-1105-2022·2022-05-25

    HeartWare HVAD Controller: Translation Errors in Critical Documentation

    The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1056-2022·2022-05-18

    Bone Graft Syringe Recall: Patient Chart Labels List Incorrect Part Numbers

    Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.

    Product
    putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2022·2022-04-13

    Vena Cava Filter Sets Recalled for Instruction for Use Documentation Updates

    Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.

    Product
    Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2022·2021-12-22

    Orthopedic Femur Plate Recalled for Incorrect MRI Safety Information

    Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2022·2021-11-10

    Arietta 750 Ultrasound Software Versions Affected by Incorrect Measurement Display

    FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.

    Product
    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·21V836000·2021-10-25

    Yamaha Recalls 2021 Tracer 9 GT for Incorrect VIN Label

    Yamaha is recalling 2021 Tracer 9 GT motorcycles because the VIN on the certification label may not match the vehicle's stamped VIN, potentially preventing owners from receiving safety recall remedies.

    Product
    YAMAHA — YAMAHA TRACER 9 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2021·2021-08-11

    AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions

    The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.

    Product
    Kaguya Automated Peritoneal Dialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1828-2021·2021-06-16

    VIA Microcatheter recalled due to incorrect international labeling shipped to US

    MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.

    Product
    VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0601-2021·2021-06-09

    Thiamine HCl Injection Recall: Vials with Incorrect Lot Numbers

    Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection USP 200 mg/2 mL due to vials labeled with incorrect lot numbers. The cartons contain the correct lot number 200906 but vials inside are labeled with lot number 200901.

    Product
    THIAMINE HYDROCHLORIDE — THIAMINE HYDROCHLORIDE (THIAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Recall

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update guidance on intermittent alarm issues.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1426-2021·2021-04-28

    HeartWare HVAD System Manual Updates for Carrying Cases and Driveline Cover

    Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowNHTSA·21V237000·2021-04-05

    Mercedes-Benz Sprinter VIN Mismatch Recall

    Daimler Vans USA is recalling one 2019 Mercedes-Benz Sprinter because its VIN numbers do not match, potentially preventing owners from receiving safety recall notices.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0401-2021·2020-11-25

    Merz Recalls COAPTITE Injectable Implant Due to Documentation Mismatch

    Merz North America is recalling 2,051 units of COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data.

    Product
    COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-0288-2021·2020-11-04

    Blue Ortho Recalls GPS Tracker Instructions Due to Sterilization Language

    Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.

    Product
    Instructions For Use document of the GPS Trackers.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0105-2021·2020-10-21

    Cook Inc. Recalls Percutaneous Neonatal Pigtail Nephrostomy Sets

    Cook Inc. is recalling 368 Percutaneous Neonatal Pigtail Nephrostomy Sets because the indwell time is decreasing from 4 months to 4 weeks.

    Product
    Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0013-2021·2020-10-14

    Nettle Meadow Artisan Cheese Recalled Due to Unrecorded Pasteurization Temperature

    LuMaZu, LLC dba Nettle Meadow is recalling two cases of Habanero Peach Fromage Frais because pasteurization temperatures were not recorded due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Habanero Peach Fromage Frais***Contains pasteurized goat and cows milk*** 5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0012-2021·2020-10-14

    Nettle Meadow Truffle Fromage Frais Recalled Due to Pasteurization Record Failure

    LuMaZu, LLC dba Nettle Meadow is recalling 16 units of Truffle Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Truffle Fromage Frais***Contains pasteurized goat and cows milk*** 5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0011-2021·2020-10-14

    Nettle Meadow Artisan Cheese Recalled Due to Pasteurization Recording Failure

    LuMaZu, LLC dba Nettle Meadow is recalling artisan cheese because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Roasted Red Pepper Fromage Frais***Contains pasteurized goat and cows milk***5 oz."
    Category
    Food
    Distribution
    8 states
  • LowFDA (Devices)·Z-0070-2021·2020-10-14

    Devicor Neoprobe GDS Control Unit Recalled for Software Version Mismatch

    Devicor Medical Products Inc is recalling 49 Neoprobe GDS Control Units distributed to China because the installed software version does not match the approved version.

    Product
    Neoprobe GDS Control Unit, Model Number NPCU3
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1381-2020·2020-07-15

    Biogen Recalls Tecfidera Capsules Due to Quality Control Deviations

    Biogen MA Inc. is recalling 3,922 bottles of Tecfidera (dimethyl fumarate) 240 mg capsules because a rejected lot was distributed to US markets.

    Product
    TECFIDERA — TECFIDERA (DIMETHYL FUMARATE)
    Category
    Drug
    Distribution
    3 states
  • LowNHTSA·20V372000·2020-06-24

    Volkswagen Recalls Two 2018 Golf GTI Vehicles for VIN Label Mismatch

    Volkswagen is recalling two 2018 Golf GTI vehicles because the VIN on the Federal Certification label may not match the actual vehicle VIN, potentially preventing owners from identifying safety recalls.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V327000·2020-06-05

    Class C Motorhome Manual Error Increases Rollaway Risk for 2019–2021 Models

    Jayco is recalling certain 2019–2021 Class C motorhomes because the Operator's Manual contains incorrect information about the automatic parking function, which could lead to unintended vehicle movement or rollaway.

    Product
    ENTEGRA — ENTEGRA, JAYCO QWEST, MELBOURNE, MELBOURNE PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1277-2020·2020-06-03

    LidoPatch Pain Relief Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling LidoPatch pain relief patches because missing manufacturing records prevent verification that the product remains within specification through its expiration date.

    Product
    LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1894-2020·2020-05-13

    Abbott Recalls C Peptide Calibrators Due to Mexico License Documentation Error

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

    Product
    ARCHITECT C Peptide Calibrator - 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
  • 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