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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25726–25750 of 27722

  • HighFDA (Devices)·Z-0524-2014·2013-12-25

    GE Recalls InstaTrak and ENTrak Computer-Assisted Navigation Systems

    GE OEC Medical Systems is recalling InstaTrak and ENTrak navigation systems due to potential safety issues.

    Product
    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2014·2013-12-25

    Intuitive Surgical Recalls Mega Needle Drivers for Potential Jaw Detachment

    Intuitive Surgical is recalling Mega Needle Drivers for the da Vinci S and Si systems due to a potential risk of jaw insert detachment.

    Product
    Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2014·2013-12-25

    ASI Medical Recalls SEAC Advanced Dental Systems Due to Air Tank Rupture Risk

    ASI Medical is recalling 337 SEAC Advanced Dental Systems because the miniature plastic air tank can potentially rupture.

    Product
    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2014·2013-12-25

    Roche MagNA Pure 96 System Recalled for Potential Sample Mismatch

    Roche Diagnostics is recalling 27 MagNA Pure 96 Systems due to a software issue that may cause sample mismatches when importing XML files.

    Product
    MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0550-2014·2013-12-25

    Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0522-2014·2013-12-25

    Mobility Unlimited Recalls KayserBetten IDA Beds Due to Door Joint Failure

    Mobility Unlimited Inc. is recalling 33 KayserBetten model IDA beds because door joints may loosen or separate, causing doors to drop outward and potentially injure users.

    Product
    KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2014·2013-12-25

    Siemens Recalls Dimension TACR Flex Reagent Cartridges for Stability Issues

    Siemens is recalling Dimension TACR Flex reagent cartridges because reduced stability may cause inaccurate test results for transplant patients.

    Product
    Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2014·2013-12-25

    Intuitive Surgical Recalls Large Needle Drivers Due to Jaw Insert Detachment Risk

    Intuitive Surgical is recalling Large Needle Drivers for the da Vinci S and Si systems because the jaw insert may detach during use.

    Product
    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2014·2013-12-25

    Remel Inc Recalls Streptex Kits Due to Potential False Negative Results

    Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.

    Product
    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2014·2013-12-25

    Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0518-2014·2013-12-25

    Kimberly-Clark Epidural Pain Management Trays Recalled for Syringe Defect

    Kimberly-Clark is recalling Single Shot Epidural Pain Management Trays because the included BD LOR Syringes may stall or stick.

    Product
    Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2014·2013-12-25

    Ortho-Clinical Diagnostics Recalls VITROS CA 125 II Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 125 II Calibrators due to a positive shift in patient results.

    Product
    VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2014·2013-12-25

    Integra Epidural Anesthesia Kits Recalled Due to Syringe Plunger Defect

    Integra LifeSciences is recalling specific lots of epidural anesthesia kits because the included BD LOR syringe plunger may stall or stick.

    Product
    Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2014·2013-12-25

    Siemens Dimension Vista Homocysteine Reagent Cartridge Recalled for Erratic Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Homocysteine Flex Reagent Cartridges due to erratic quality control and patient sample recovery.

    Product
    Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid…
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0427-2014·2013-12-18

    Cutera truSculpt Infrared System Recalled for Thermal Burn Risk

    Cutera is recalling 451 truSculpt infrared systems because the device caused partial thickness thermal burns to the skin in two patients.

    Product
    Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0458-2014·2013-12-18

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Recalled

    Ethicon is recalling Stratafix Symmetric PDS Plus Knotless Tissue Control Devices due to reported tab failures and fascial dehiscences in lower abdominal incisions.

    Product
    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2014·2013-12-18

    Zimmer Trabecular Metal Total Ankle Tibial Base Component Recall

    Zimmer, Inc. is recalling specific sizes of the Trabecular Metal Total Ankle Tibial Base Component due to potential elevated levels of manufacturing residue.

    Product
    Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2014·2013-12-18

    IBA COMPASS Software Recall for Erroneous Dose Statistics

    IBA Dosimetry GmbH is recalling COMPASS SW Version 3.0 due to a software defect that causes erroneous dose statistics and DVHs.

    Product
    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0470-2014·2013-12-18

    Beckman Coulter Recalls LH 750 Hematology Analyzers Due to Optical Degradation

    Beckman Coulter is recalling LH 750 Hematology Analyzers because optical degradation may delay reporting results for specific blood cell counts.

    Product
    Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2014·2013-12-18

    Zimmer Total Ankle Components Recalled for Manufacturing Residue

    Zimmer, Inc. is recalling specific Total Ankle Talar Components due to potential elevated levels of manufacturing residue on the implants.

    Product
    Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2014·2013-12-18

    Arrow Transradial Artery Access Products Recalled for Occluded Needles

    Arrow International Inc is recalling Transradial Artery Access products because introducer needles may be occluded, posing a risk of delayed treatment or adverse events.

    Product
    Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2014·2013-12-18

    GE Healthcare Patient Monitors Recalled for Incorrect ECG Filter Settings

    GE Healthcare is recalling specific patient monitors because they may apply an incorrect ECG filter setting if impedance respiration is enabled at startup.

    Product
    HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2014·2013-12-18

    Maquet Vasoview Hemopro Endoscopic Vessel Harvesting System Recalled for Overheating

    Maquet Cardiovascular is recalling 12,259 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System due to complaints that the device self-activates or overheats.

    Product
    Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2014·2013-12-18

    Zimmer NexGen Knee Instruments Recalled Due to Surgical Delay Risk

    Zimmer, Inc. is recalling five NexGen knee instruments to prevent their inadvertent use during surgery, which could cause delays.

    Product
    NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2014·2013-12-18

    Trumpf Medical Systems Recalls Helion S and H300 Exam Lights

    Trumpf Medical Systems is recalling 287 Helion S and H300 exam lights because a plastic joint may fail due to fatigue after seven years of use.

    Product
    Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
    Category
    Medical Device
    Distribution
    16 states