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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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16051–16075 of 27500

  • HighFDA (Devices)·Z-1263-2019·2019-05-08

    GE Healthcare Recalls NM/CT 860 Systems Due to Detector Screw Issue

    GE Healthcare is recalling six NM/CT 860 systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1261-2019·2019-05-08

    GE Healthcare Recalls NM 830 Nuclear Imaging Systems for Screw Defect

    GE Healthcare is recalling 37 Discovery NM 830 nuclear imaging systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1247-2019·2019-05-08

    Siemens CT Scanners Recalled for Dual Energy Scan Abortion Risk

    Siemens is recalling 53 SOMATOM Definition AS CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2019·2019-05-08

    GE Healthcare Recalls Optima NM/CT 640 Systems for Detector Screw Issue

    GE Healthcare is recalling 35 Optima NM/CT 640 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.

    Product
    Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1262-2019·2019-05-08

    GE Healthcare Recalls NM/CT 850 Systems Due to Detector Screw Issue

    GE Healthcare is recalling 31 NM/CT 850 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1240-2019·2019-05-08

    Philips MR Systems Recalled for Magnet Energization Device Electrical Shock Risk

    Philips is recalling four Ingenia Ambition MR systems because the Magnet Energization Device may have residual voltage, posing an electrical shock risk to personnel.

    Product
    Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1259-2019·2019-05-08

    GE Discovery NM/CT 670 DR Recalled for Potential Detector Screw Issue

    GE Healthcare is recalling 11 Discovery NM/CT 670 DR systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1257-2019·2019-05-08

    GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems

    GE Healthcare is recalling 57 Discovery NM 630 nuclear imaging systems because detector screws may not be secured correctly, risking loss of mounting redundancy.

    Product
    Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1225-2019·2019-05-08

    DePuy Spine Recalls Concorde Lift Spinal Fusion Implants

    DePuy Spine is recalling Concorde Lift spinal fusion implants due to a complaint trend of post-operative loss of height and migration.

    Product
    Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1116-2019·2019-05-01

    Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters

    Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.

    Product
    Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1117-2019·2019-05-01

    Edwards Miller Balloon Atrioseptostomy Catheter Recalled for Deflation Issues

    Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to difficulty deflating the balloon and reports of fragmentation or detachment.

    Product
    Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2019·2019-05-01

    Covidien Endo Clinch II Auto Suture Grasper Recalled for Sterilization Issues

    COVIDIEN LLC is recalling 7,248 units of the Endo Clinch II Auto Suture Grasper because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2019·2019-05-01

    TriMed Hex Cortical Screw Recalled for Shorter Than Specified Length

    TriMed Inc. is recalling 13 Hex Cortical Screws from the Ankle Fixation System because they are shorter than the intended design specification.

    Product
    TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1217-2019·2019-05-01

    FDA Recalls Safety Winged Blood Collection Sets Due to Needle Detachment

    Guangzhou Improve Medical Instruments is recalling 550,000 Prevent G Safety Winged Blood Collection Sets because the hub needle detached during use.

    Product
    Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2019·2019-05-01

    Fresenius Kabi CATSmart Autotransfusion Device Recalled for Tubing Wear Risk

    Fresenius Kabi is recalling 342 CATSmart autotransfusion devices because tubing may contact the washing chamber, causing wear or puncture.

    Product
    Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2019·2019-05-01

    Brainlab RT Elements Software Recalled for Incorrect Dose Calculation

    Brainlab AG is recalling specific versions of RT Elements software due to a potential for incorrect dose distribution calculations when using the Pencil Beam algorithm on the GPU.

    Product
    RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2019·2019-05-01

    Siemens Digital Linear Accelerators Recalled for Motion Protection Safety Advisory

    Siemens Medical Solutions USA is recalling 120 digital linear accelerators nationwide to prevent patient or user injury from disabling the Automatic Motion Protection function.

    Product
    Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2019·2019-05-01

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling 80 VITROS XT 7600 Integrated Systems because a software error may cause incorrect test results without alerting the user.

    Product
    VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2019·2019-05-01

    Thoratec HeartMate 3 Coring Tool Recalled for Foreign Particle Contamination

    Thoratec Corp. is recalling HeartMate 3 Coring Tools because a small black plastic particle was observed in a patient's left ventricle during an implant procedure.

    Product
    Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2019·2019-05-01

    Arthrex Burr Recalled for Excessive Heat Generation During Use

    Arthrex, Inc. is recalling specific lots of Arthrex Oval Burr devices because they may generate excessive heat during use, posing a risk of injury to patients.

    Product
    Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2019·2019-05-01

    Stryker Performance Series Sagittal Blade Recall for Sterility Breach

    Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.

    Product
    Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2019·2019-05-01

    Jelco ViaValve Safety Intravenous Catheters Recalled for Manufacturing Defect

    Smiths Medical ASD Inc. is recalling specific lots of Jelco ViaValve safety intravenous catheters due to a V-shaped puncture at the base of the catheter.

    Product
    Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1082-2019·2019-04-24

    Brainlab Spine & Trauma 3D Navigation Software Recall for Display Error

    Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.

    Product
    Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide