The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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36301–36325 of 40449

  • HighFDA (Devices)·Z-1124-2014·2014-03-12

    Medical Information Technology Recalls MEDITECH Microbiology Calculator Module

    Medical Information Technology, Inc. is recalling MEDITECH Microbiology calculator modules due to a risk of patient results being removed from laboratory and electronic medical record systems.

    Product
    MEDITECH Microbiology - Calculator/data processing module, for clinical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2014·2014-03-12

    Carestream Recalls Kodak 2100 Intraoral X-Ray Systems Due to Arm Breakage

    Carestream Health is recalling Kodak 2100 Intraoral X-Ray Systems because the device arms may break early. The recall covers 347 units distributed in the US and Canada.

    Product
    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2014·2014-03-12

    KCI Recalls Prevena Incision Management System Due to Connector Difficulty

    KCI USA is recalling 20,850 units of the Prevena Incision Management System because the tubing connector is difficult to attach to the canister.

    Product
    PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2014·2014-03-12

    AlterG Anti-Gravity Treadmill Accessory Shorts Recalled for Unapproved Material

    AlterG, Incorporated is recalling 2,221 accessory shorts for the AlterG Anti-Gravity Treadmill because unapproved material caused them to stretch unusually, making them uncomfortable for patients.

    Product
    Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1148-2014·2014-03-12

    GE Healthcare GSI Viewer Software Recall for Inaccurate Line Measurements

    GE Healthcare is recalling GSI Viewer software because changing the region of interest or zooming may result in inaccurate line measurements.

    Product
    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2014·2014-03-12

    Mako Surgical Recalls Restoris Multicompartmental Knee System Due to Mislabeling

    Mako Surgical Corporation is recalling 41 units of the Restoris Multicompartmental Knee System because the product may be mislabeled, which could result in the incorrect implant being used.

    Product
    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1129-2014·2014-03-12

    Medicamat Punch Hair Matic Recalled for Misbranded Marketing Literature

    Medicamat is recalling 71 units of the Punch Hair Matic surgical hair transplant device due to misbranded marketing literature.

    Product
    Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1146-2014·2014-03-12

    Horiba Medical Recalls ABX PENTRA Calibrators Due to Updated Target Values

    Horiba Medical is recalling ABX PENTRA calibrators and controls because target values for the Creatinine Rate Blank Method were updated.

    Product
    ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0973-2014·2014-03-12

    Medtronic O-arm Imaging System Recalled for Labeling Compliance Gaps

    Medtronic is recalling O-arm Imaging Systems because a review found gaps in compliance with FDA labeling requirements for user information.

    Product
    Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1125-2014·2014-03-12

    Synthes 5.0mm Variable Locking Screw Recalled for Incorrect Package Insert

    Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws because one package contained the wrong insert.

    Product
    Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1123-2014·2014-03-12

    AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 169 units of TECNIS CL Foldable Silicone IOLs because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2014·2014-03-12

    KCI Recalls Prevena Customizable Dressing Due to Connector Difficulty

    KCI USA is recalling 20,850 units of Prevena Customizable Dressing 5-Packs because the tubing connector is difficult to attach to the canister.

    Product
    PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0972-2014·2014-03-12

    Toshiba CT System Recalled Due to X-Ray Generator Failure

    Toshiba is recalling eight Aquilion One CT systems because high-voltage generator parts may fail, preventing X-ray exposure.

    Product
    TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1130-2014·2014-03-12

    DJO Surgical Recalls Mispackaged Acetabular Liners for Hip Replacement

    DJO Surgical is recalling 10 units of FMP X-alt Acetabular Liners that were mistakenly packaged and labeled as different models and sizes.

    Product
    FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2014·2014-03-12

    KCI Prevena Peel and Place System Kit Recalled for Connector Issues

    KCI USA is recalling Prevena Peel and Place System Kits because the male tubing connector is difficult to connect to the female canister connector.

    Product
    PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1065-2014·2014-03-12

    Elekta Digital Accelerators Recalled for Default Value Reset Issues

    Elekta, Inc. is recalling 472 digital accelerators because customers are resetting default values outside recommended factory settings.

    Product
    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2014·2014-03-12

    WalkMed Recalls Triton FP Infusion Pumps Due to Labeling Error

    WalkMed Infusion is recalling 797 Triton FP Infusion Pumps because the label on the right side contains an incorrect instruction.

    Product
    Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1144-2014·2014-03-12

    Focus Diagnostics Recalls Simplexa Flu and RSV Assay Kits

    Focus Diagnostics is recalling Simplexa Flu A/B & RSV Direct Assay Kits due to the potential for false positive test results.

    Product
    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1126-2014·2014-03-12

    Hospira Recalls LifeShield Blood Sets Due to Assembly Errors

    Hospira Inc. is recalling specific lots of LifeShield Latex-Free HEMA Y-Type Blood Sets because they were assembled incorrectly.

    Product
    *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2014·2014-03-12

    KCI USA Recalls Prevena Customizable Dressing 5-Pack Due to Connector Issue

    KCI USA is recalling 20,850 units of the Prevena Customizable Dressing 5-Pack because the male connector on the tubing is difficult to connect to the female connector on the canister tubing.

    Product
    PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2014·2014-03-12

    KCI USA Recalls Prevena Peel and Place System Kits

    KCI USA is recalling Prevena Peel and Place System Kits because the tubing connector is difficult to connect to the canister.

    Product
    PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2014·2014-03-12

    KCI Recalls Prevena Incision Management System Kits Due to Connector Issues

    KCI USA is recalling Prevena Incision Management System kits because the male tubing connector is difficult to attach to the female canister connector.

    Product
    PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1137-2014·2014-03-12

    KCI Recalls Prevena Dressing Kits Due to Connector Connection Issues

    KCI USA is recalling 20,850 Prevena Dressing kits because the male tubing connector is difficult to connect to the female canister connector.

    Product
    PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1133-2014·2014-03-12

    BencoDental Tartar and Stain Remover Recalled for Incorrect Labeling

    Heraeus Kulzer is recalling BencoDental tartar and stain remover due to incorrect labeling on the immediate container.

    Product
    BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2014·2014-03-12

    KCI Recalls Prevena Dressing Kits Due to Connector Connection Difficulty

    KCI USA is recalling 20,850 Prevena Dressing kits because the tubing connector is difficult to connect to the canister.

    Product
    PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing…
    Category
    Medical Device
    Distribution
    Distributed nationwide