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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33626–33650 of 40449

  • HighFDA (Devices)·Z-1065-2015·2015-02-18

    SCC Soft Computer Recalls SoftPath Laboratory Information System Versions

    SCC Soft Computer is recalling specific versions of the SoftPath Laboratory Information System because diagnostic text modifications may not be saved or displayed correctly.

    Product
    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2015·2015-02-18

    Maquet Intra-Aortic Balloon Pump Demonstration Units Recalled for Ferrule Cap Defect

    Maquet Datascope is recalling specific intra-aortic balloon pump demonstration units because a ferrule cap was not removed, which could prevent connection or become dislodged in the device.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1082-2015·2015-02-18

    Arrow International Recalls Two-Lumen CVC Kits Due to Foreign Material

    Arrow International Inc is recalling 1,195 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because visible foreign material was found inside the kits.

    Product
    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2015·2015-02-18

    Elekta Precise Digital Accelerator Recall for Potential Securing Bolt Failure

    Elekta is recalling 46 Precise Digital Accelerators because securing bolts for the gantry counter frame weight stack may fail.

    Product
    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1110-2015·2015-02-18

    Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues

    Arthrosurface, Inc. is recalling 136 units of HemiCAP shoulder prosthetic components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1066-2015·2015-02-18

    Stryker Recalls System 6 Aseptic Housings Due to Weld Defect

    Stryker is recalling 399 System 6 Aseptic Housings because a failed test revealed a lack of a continual weld. Customers are instructed to return the product to Stryker.

    Product
    System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2015·2015-02-18

    Teleflex Recalls Preformed Tracheal Tubes Due to Incorrect Labeling

    Teleflex Medical is recalling 300 units of preformed tracheal tubes because they are incorrectly labeled as cuffed oral tubes instead of uncuffed nasal tubes.

    Product
    Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1093-2015·2015-02-18

    Stryker Recalls MEDPOR Titan Max Orbital Floor and Wall Implants

    Stryker is recalling MEDPOR Titan Max Orbital Floor and Wall implants due to incorrect barrier location and potential mix-ups with left-sided units.

    Product
    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2015·2015-02-18

    TeraRecon Recalls Aquarius iNtuition Client Viewer Software Due to Anomaly

    TeraRecon is recalling 91 units of the Aquarius iNtuition Client Viewer due to a software anomaly in the RECIST 1.1 evaluation criteria.

    Product
    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2015·2015-02-18

    Teleflex Recalls Hudson RCI Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling specific Hudson RCI Humidifier Adaptors because the packages may contain black particles. The recall affects units distributed worldwide.

    Product
    Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1108-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1105-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain foreign material, specifically black particles.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2015·2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 used in the Xltek Protektor Stimulator. A software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1112-2015·2015-02-18

    Arthrosurface Shoulder Prosthesis Components Recalled for Uncleared Marketing Status

    Arthrosurface, Inc. is recalling 138 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1113-2015·2015-02-18

    Arthrosurface Recalls Uncleared Taper Post Fixation Components

    Arthrosurface, Inc. is recalling 182 units of Athrosurface Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2015·2015-02-18

    Biomet Spine Recalls Timberline Cranial Caudal and Posterior Blades

    Biomet Spine, LLC is recalling Timberline Cranial Caudal and Posterior Blades due to an oversize set screw hex feature.

    Product
    Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1085-2015·2015-02-18

    Teleflex Recalls LMA Supreme Size 5 Due to Potential Size 4 Mislabeling

    Teleflex Medical is recalling 2,640 units of LMA Supreme (New Cuff) Size 5 devices because some may be mislabeled as Size 5 but are actually Size 4.

    Product
    LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2015·2015-02-18

    Arthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance

    Arthrosurface, Inc. is recalling 187 units of the HHXL (OVO) 15.6x32mm Taper Post Fixation Component because the product was not cleared for marketing in the US with its current indications.

    Product
    Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2015·2015-02-18

    Zimmer Dental Recalls GemLock Long Hex Driver Due to Fit Issues

    Zimmer Dental Inc is recalling 627 GemLock Long Hex Drivers because they may not fit into the Fixture Mount Transfer or the implant's internal hex.

    Product
    GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1067-2015·2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 because a software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1080-2015·2015-02-18

    Arrow Epidural Needle Component Recalled for Missing Shelf Life Labeling

    Arrow International Inc. is recalling 63,022 units of ARROW Epidural Needle Components because the product labeling does not specify the 5-year shelf life.

    Product
    ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1094-2015·2015-02-18

    Synthes Recalls Hemostatic Bone Putty Due to Incorrect Brochure Revision

    Synthes, Inc. is recalling 38 units of Hemostatic Bone Putty because Revision A of the brochure was distributed instead of the corrected Revision B.

    Product
    Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1076-2015·2015-02-18

    MAST Biosurgery Recalls SurgiWrap Film Due to Expiration Date Mismatch

    MAST Biosurgery is recalling 49 units of SurgiWrap Bioresorbable Adhesion Barrier Film because the expiration date on the barcode did not match the printed date.

    Product
    The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1081-2015·2015-02-18

    Lacrimedics Recalls VisiPlugST Devices Due to Moisture-Related Breakage

    Lacrimedics Inc is recalling VisiPlugST devices because moisture levels may cause the plugs to break apart or crumble upon contact.

    Product
    VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm.…
    Category
    Medical Device
    Distribution
    Distributed nationwide