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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20926–20950 of 40248

  • 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
  • ModerateFDA (Devices)·Z-1244-2019·2019-05-08

    Siemens CT Scanner Recall Due to Software Issue in Dual Spiral Mode

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

    Product
    SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1238-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Potential Measurement Inaccuracy

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1260-2019·2019-05-08

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

    GE Healthcare is recalling three Discovery NM/CT 670 ES systems because detector screws may not have been secured correctly during installation.

    Product
    Discovery NM/CT 670 ES 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
  • ModerateFDA (Devices)·Z-1264-2019·2019-05-08

    GE Healthcare Recalls 16 NM/CT 870 CZT Systems for Screw Issue

    GE Healthcare is recalling 16 NM/CT 870 CZT systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT 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…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1243-2019·2019-05-08

    Molnlycke Recalls EZ Derm Porcine Xenograft Due to Heat Seal Failures

    Molnlycke Health Care is recalling 1,332 units of EZ Derm Porcine Xenograft due to intermittent heat seal failures on the outer pouch.

    Product
    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2019·2019-05-08

    BioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results

    BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.

    Product
    FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1235-2019·2019-05-08

    Siemens Atellica IM aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling 1,489 Atellica IM aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1223-2019·2019-05-08

    Matrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is voluntarily recalling 46 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1236-2019·2019-05-08

    Siemens Atellica IM aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling 114 Atellica IM aTG test kits because they show positive bias compared to WHO standards.

    Product
    Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2019·2019-05-08

    Matrix Surgical Recalls 42 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is recalling 42 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2019·2019-05-08

    Randox G-6-PDH Deficient Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 14 kits of G-6-PDH Deficient Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1246-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Mode

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

    Product
    SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1237-2019·2019-05-08

    PerkinElmer Recalls DELFIA hCG Kits Due to Measurement Inaccuracy

    PerkinElmer is recalling 31 DELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2019·2019-05-08

    Randox G-6-PDH Normal Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 10 kits of G-6-PDH Normal Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1233-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1234-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1265-2019·2019-05-08

    GE Healthcare Recalls 27 NM/CT 870 DR Systems Due to Detector Screw Issue

    GE Healthcare is recalling 27 NM/CT 870 DR systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.

    Product
    NM/CT 870 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, abnormalities…
    Category
    Medical Device
    Distribution
    0 states