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

Agency

Category

Minimum severity

Clear filters

17476–17500 of 27505

  • HighFDA (Devices)·Z-2593-2018·2018-08-08

    MAYFIELD Infinity XR2 Base Unit Recalled Due to Fracture Risk

    Integra LifeSciences is recalling 17 MAYFIELD Infinity XR2 Base Units because the knob assembly may fracture during use.

    Product
    MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2018·2018-08-08

    Galt Medical Recalls Sterile Access Kits Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific sterile transcarotid and peripheral access kits because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2592-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units

    Integra LifeSciences is recalling 409 Mayfield Infinity XR2 Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2576-2018·2018-08-08

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Latex Labeling Error

    Arrow International is recalling 60 units of Percutaneous Sheath Introducer Kits because the product contains dry natural rubber latex but is labeled as latex-free.

    Product
    Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2565-2018·2018-08-08

    Galt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific lots of Tearaway Introducers because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2566-2018·2018-08-08

    Merge Unity Software Recalled for Incorrect Breast Cancer Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0.6 and 10.0.7 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations for breast cancer.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2018·2018-08-08

    Siemens SOMATOM Scope Power Recalled for Software Radiation Risk

    Siemens is recalling SOMATOM Scope Power units due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Scope Power (Model 10967888)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2018·2018-08-08

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Radiation Risk

    Siemens Medical Solutions is recalling SOMATOM Emotion 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Emotion 16 (10165977)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2018·2018-08-08

    QIAGEN Recalls EZ1 DSP Virus Kit Due to Underfilled Reagent Wells

    QIAGEN is recalling 287 units of the EZ1 DSP Virus Kit (48) because underfilled reagent wells could lead to incorrect diagnostic results.

    Product
    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2571-2018·2018-08-08

    Cayenne Medical Recalls Quattro Link Drills Due to Breakage Trend

    Cayenne Medical Inc. is recalling 229 Quattro Link drills because a review of complaints identified a trend for the devices breaking.

    Product
    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2570-2018·2018-08-08

    XLTEK EMU40EX EEG Headbox Recalled for Component Degradation

    Natus Neurology is recalling 462 XLTEK EMU40EX EEG Headboxes because an internal electronic component may degrade, causing the unit to overheat and the plastic case to melt.

    Product
    XLTEK EMU40EX EEG Headbox
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2597-2018·2018-08-08

    Baxter Recalls Power Cords for AMIA Automated PD Cycler

    Baxter Healthcare is recalling power cords for the AMIA Automated PD Cycler because the socket may detach when unplugged.

    Product
    power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2584-2018·2018-08-08

    GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Revolution EVO 3.6 CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

    Product
    Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2018·2018-08-08

    Galt Medical Recalls Centesis Catheters Due to Bacterial Endotoxin Contamination

    Galt Medical Corporation is recalling specific lots of Drainer and Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2580-2018·2018-08-08

    GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Discovery MI CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

    Product
    Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2018·2018-08-08

    Siemens SOMATOM Perspective 16 CT Scanner Recalled for Software Issue

    Siemens Medical Solutions USA is recalling SOMATOM Perspective 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Perspective 16 (Model 10891666)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2548-2018·2018-08-01

    Cayenne Medical Recalls AperFix Femoral Implant Coring Removal Drills

    Cayenne Medical Inc. is recalling specific models of the AperFix Femoral Implant Coring Removal Drill due to a trend of premature wear and breakage identified in 2010.

    Product
    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2018·2018-08-01

    DePuy CORAIL Femoral Stems Recalled Due to Incorrect Size Labeling

    DePuy Orthopaedics is recalling two lots of CORAIL femoral stems labeled as Size 11 but actually Size 12 due to fit and mechanical risks.

    Product
    CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2498-2018·2018-08-01

    Philips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2018·2018-08-01

    Siemens AXIOM Artis Angiography System Recalled for Defective Sealing

    Siemens is recalling six AXIOM Artis angiography systems in the US due to a defective sealing that could allow coolant to leak into electrical parts.

    Product
    AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    7 states