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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18851–18875 of 27647

  • HighFDA (Devices)·Z-0409-2018·2018-01-31

    Smith & Nephew Taylor Spatial Frame Software Recalled for Image Inversion

    Smith & Nephew is recalling Taylor Spatial Frame software versions 5.2.5 and 5.2.6 because the software may generate inverted images of the frame during strut adjustment planning.

    Product
    Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0399-2018·2018-01-31

    Medtronic MyCareLink Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring notifications.

    Product
    MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0401-2018·2018-01-31

    Sorin CP5 Centrifugal Pump Recalled for Delayed Air Bubble Detection Response

    Sorin Group is recalling CP5 Centrifugal Pumps because the automatic line closure after air bubble detection may take longer than intended.

    Product
    CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0403-2018·2018-01-31

    Philips Brilliance iCT CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling 559 Brilliance iCT CT systems due to software issues affecting scan functions and safety features.

    Product
    Brilliance iCT - Model 728306 Computed Tomography X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2018·2018-01-31

    Medtronic MyCareLink Smart Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Smart Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring alerts.

    Product
    MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0380-2018·2018-01-24

    RayStation 6 Proton QA Module Recall for Potential Dosage Errors

    RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.

    Product
    RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0350-2018·2018-01-24

    Merge Healthcare Recalls Power Strips in Hemo System Due to Overheating

    Merge Healthcare is recalling 1,150 power strips sold with the Merge Hemo System because an input resistor can overheat and cause the unit to smoke.

    Product
    Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2018·2018-01-24

    Zoll LifeVest Wearable Defibrillator Recalled for Defibrillation Shock Failure Risk

    Zoll Manufacturing Corp. is recalling 33,670 LifeVest Wearable Defibrillators due to an incorrect service code that may prevent the device from detecting critical defects, potentially leading to defibrillation shock failure.

    Product
    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2018·2018-01-24

    Roche Recalls Automated Analyzers Due to Possible Sample Mismatch

    Roche Diagnostics is recalling 2,517 automated laboratory analyzers due to a software limitation that may cause sample mismatches.

    Product
    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0389-2018·2018-01-24

    Philips Brilliance 64 CT Scanner Recalled for Fastener Torque Issues

    Philips is recalling one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.

    Product
    Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0391-2018·2018-01-24

    Philips Ingenuity Core 128 CT Scanner Recall for Fastener Torque Issues

    Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0351-2018·2018-01-24

    Hologic Recalls Affirm Lateral Arm Upright Biopsy Accessory Due to Component Issue

    Hologic, Inc. is correcting 12 Affirm Lateral Arm Upright Biopsy Accessories in the U.S. due to a component issue that could impact needle alignment during lateral biopsy procedures.

    Product
    Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0386-2018·2018-01-24

    Fujifilm Aspire Cristalle Mammography Machine Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down unintentionally.

    Product
    ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0382-2018·2018-01-24

    Owen Mumford Recalls Unifine Pentips Pen Needles Due to Sterility Concerns

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Consumers should check for discoloration on the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2018·2018-01-24

    Philips Ingenuity Core CT Scanner Recall for Fastener Torque Verification

    Philips is recalling one Ingenuity Core CT scanner because certain fasteners cannot be confirmed to be torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states