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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25751–25775 of 40357

  • LowFDA (Devices)·Z-3204-2017·2017-10-04

    Zimmer Dental Guide Sleeves Recalled for Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental guide sleeves because they were shipped with only standard instructions, missing required supplemental instructions.

    Product
    Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3207-2017·2017-10-04

    Zimmer Dental Recalls Try-In Abutments Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental try-in abutments because they were shipped with standard instructions but lacked required supplemental instructions.

    Product
    TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3210-2017·2017-10-04

    Zimmer Dental Recalls Implants Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling 169 dental implants because they were shipped without supplemental instructions for use.

    Product
    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3206-2017·2017-10-04

    Zimmer Dental Recalls Abutment and Coping Products for Missing Instructions

    Zimmer Biomet is correcting dental abutments and copings because they were shipped with standard instructions but missing supplemental instructions.

    Product
    ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3143-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic Navigation is recalling Spine Referencing Instrumentation sets due to a risk that clamps may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3141-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic Navigation is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall units due to a risk of component breakage or damage during use.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3139-2017·2017-09-27

    Medtronic Spine Referencing Clamp Recall for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation clamps due to a risk of breakage that could leave components in the patient's body.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3140-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic is recalling Spine Referencing Instrumentation because the clamps may be damaged if opened beyond limits, potentially leaving components in the patient.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3142-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of…
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-3137-2017·2017-09-27

    Medtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties

    Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 105,633 units distributed worldwide.

    Product
    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3135-2017·2017-09-27

    Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error

    Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.

    Product
    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3136-2017·2017-09-27

    Medtronic Euphora Balloon Catheter Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 69,081 units distributed in the US and worldwide.

    Product
    Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3134-2017·2017-09-27

    BioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures

    BioMérieux is recalling VITEK 2 GP ID cards because they are producing atypical negative reactions for a specific quality control strain, causing testing failures.

    Product
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3138-2017·2017-09-27

    Kamiya Biomedical Recalls K-Assay Multi-Analyte Calibrator Due to Incorrect Values

    Kamiya Biomedical is recalling specific lots of the K-Assay Multi-Analyte Calibrator because the Alpha-1 Antitrypsin (AlAT) values listed in the package insert were incorrect.

    Product
    K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4…
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-3109-2017·2017-09-20

    Leonhard Lang Skintact Defibrillation Electrodes Recalled for Connection Failure

    Leonhard Lang is recalling Skintact defibrillation electrodes that may fail to connect with ZOLL AED PLUS devices, potentially delaying life-saving treatment.

    Product
    Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2870-2017·2017-09-20

    X-Laser High-Power Laser Projectors Recalled for Safety Standard Non-Compliance

    X-Laser is recalling 830 high-power laser light show projectors because they fail to meet federal performance standards when used in auto and music modes.

    Product
    X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Devices)·Z-3117-2017·2017-09-20

    Zimmer Biomet Recalls ROSA Surgical Device Foot Switches

    Zimmer Biomet is recalling 64 ROSA surgical device foot switches that may freeze or shut down during use.

    Product
    Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3133-2017·2017-09-20

    Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues

    Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.

    Product
    Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3127-2017·2017-09-20

    Orthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core

    Orthofix is recalling six Firebird NXG Spinal Fixation System Decorticating Planers because the plastic core was found missing, which could cause scoring of the bone screw neck.

    Product
    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3130-2017·2017-09-20

    Mako Surgical Recalls Robotic Knee System Due to Software Display Error

    Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.

    Product
    Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3111-2017·2017-09-20

    Toshiba Medical Radrex-i Digital Radiography X-ray System Recalled for Software Error

    Toshiba American Medical Systems is recalling 140 Radrex-i digital radiography systems because a software error causes image loss and requires a system reboot.

    Product
    Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3120-2017·2017-09-20

    Leica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling four units of Podoplanin (D2-40 Mab) antibody because a delay in transit may have caused the product to be stored outside of required temperature limits.

    Product
    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3121-2017·2017-09-20

    Leica Biosystems Recalls Glypican-3 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling three units of Glypican-3 (1G12 Mab) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3115-2017·2017-09-20

    Implant Direct Sybron Recalls Guided Surgery Handle Kits Due to Dimensional Defect

    Implant Direct Sybron is recalling 84 Guided Surgery Handle Kits because the 2.3mm drill guide inserts have a smaller inside diameter than specifications require.

    Product
    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning…
    Category
    Medical Device
    Distribution
    Distributed nationwide