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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

21626–21650 of 40299

  • HighFDA (Devices)·Z-0582-2019·2018-12-19

    Medtronic HeartWare HVAD Battery Charger Recalled for Incorrect Inductors

    Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.

    Product
    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2019·2018-12-19

    GE Healthcare Recalls B40i Patient Monitors Due to Network Restart Risk

    GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0605-2019·2018-12-19

    Howmedica Recalls Tritanium Posterior Lumbar Cage Implants Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.

    Product
    Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0584-2019·2018-12-19

    GE Healthcare Recalls PROCARE B40 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 33,065 PROCARE B40 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0562-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Puncture Risk

    CIVCO Medical Instruments is recalling 738 boxes of Needle Guide Brackets because they may puncture the sterile cover during assembly.

    Product
    CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0577-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to broken seals that compromise sterility and increase infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0578-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to potential broken seals that compromise sterility.

    Product
    Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0583-2019·2018-12-19

    GE Healthcare Recalls PROCARE B20 Patient Monitors Due to Network Issues

    GE Healthcare is recalling 28,004 PROCARE B20 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2019·2018-12-19

    CIVCO Recalls SonoSite L25 Bracket Kits Due to Puncture Risk

    CIVCO Medical Instruments is recalling SonoSite L25 Bracket Kits because the needle guide bracket may puncture the sterile cover during assembly.

    Product
    SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0579-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0587-2019·2018-12-19

    GE Healthcare Recalls B105/125 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 5,516 B105/125 patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2019·2018-12-19

    Philips Recalls HeartStart MRx Lithium-Ion Batteries Due to Defective Component

    Philips is recalling 1,880 HeartStart MRx lithium-ion batteries because a defective component may prevent the battery from charging or delivering power to the monitor/defibrillator.

    Product
    HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0593-2019·2018-12-19

    St. Jude Medical DBS Leads Recalled for Incorrect Electrode Material

    St. Jude Medical is recalling Deep Brain Stimulation leads where the most proximal unsegmented electrode may be made of MP35N instead of the required 90/10 platinum-iridium.

    Product
    St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Puncture Risk

    CIVCO is recalling Needle Guide Brackets that may puncture the sterile cover during assembly, potentially compromising sterility.

    Product
    CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0588-2019·2018-12-19

    GE LOGIQ E10 Ultrasound System Recalled for Potential Burn Injury

    GE Healthcare is recalling 103 LOGIQ E10 Ultrasound Systems because a trans-esophageal probe may overheat, posing a risk of burn injury to patients.

    Product
    GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2019·2018-12-19

    Zimmer Biomet Recalls Orthopedic Stems Due to Potential Labeling Error

    Zimmer Biomet is recalling specific lots of orthopedic stems because they may be mislabeled, potentially extending surgery time by up to 30 minutes.

    Product
    Comprehensive Mini Stem, Item No. 113631:
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0572-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0595-2019·2018-12-19

    Angiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates

    Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with expiration dates that extend shelf life beyond validated testing.

    Product
    Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0565-2019·2018-12-19

    CIVCO Biopsy Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.

    Product
    CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0575-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.

    Product
    CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0600-2019·2018-12-19

    Tosoh AIA-900 and AIA-2000 Analyzers Recalled for Incubator Slippage Risk

    Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.

    Product
    AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0571-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled Due to Missing Product Labeling

    CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0604-2019·2018-12-19

    Binding Site Human IgM Kit Recalled for Calibration Curve Validation Issues

    The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.

    Product
    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative…
    Category
    Medical Device
    Distribution
    10 states