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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19951–19975 of 27647

  • HighFDA (Devices)·Z-1520-2017·2017-03-29

    CareFusion Alaris System PC Unit Recall for Battery Alarm Failure

    CareFusion is recalling Alaris System PC units because low battery alarms may fail to trigger before the battery discharges, stopping all infusion channels.

    Product
    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2017·2017-03-29

    Merge Eye Station Import Utility Recalled for System Lockup Risk

    Merge Healthcare is recalling the Eye Station Import Utility software because system lockups may cause patient injury or delay diagnosis.

    Product
    Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2017·2017-03-29

    Merge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 9.0.8 because users can merge device files with confirmed reports, potentially adding unverified information.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2017·2017-03-29

    Stanley Security Recalls 500 Arial Wireless Call Pendants

    Stanley Security Solutions is recalling 500 Arial Wireless Water-Resistant Call Pendants because they were incorrectly programmed, which may prevent alarms from sounding when the button is pressed.

    Product
    Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1494-2017·2017-03-29

    Nidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming

    Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12 for the EC-5000 Excimer Laser System because treatment planning could be programmed with an unintended correction.

    Product
    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2017·2017-03-29

    Merge Cardio software recall due to patient data display error

    Merge Healthcare is recalling Merge Cardio software versions with IPID because the system may display images from different patients as if they belong to the same individual.

    Product
    Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1513-2017·2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic Sofamor Danek USA Inc is recalling 72 units of Poly Component Trial knee implants because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1539-2017·2017-03-29

    Integra Recalls Panta Nails Due to Potential Sterility Seal Issues

    Integra LifeSciences is voluntarily recalling Panta and Panta XI Nails because package seals may not maintain intended sterility.

    Product
    Panta Nail, Rx only, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2017·2017-03-29

    Medtronic Recalls Poly Component Trials Due to Cracked or Broken Dovetails

    Medtronic is recalling 111 units of Poly Component Trials because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1514-2017·2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic is recalling 72 Poly Component Trial knee implants because their dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1543-2017·2017-03-29

    Medtronic Recalls Endurant Bifurcated Stent Grafts Due to Fabric Permeability

    Medtronic is voluntarily recalling specific Endurant and Endurant II bifurcated stent graft systems because fabric permeability variations may be associated with endoleaks during initial implant procedures.

    Product
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E.…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1485-2017·2017-03-29

    PureWick External Catheter Recalled for Latex Labeling Errors

    Purewick Corporation is recalling 176,863 units of the PureWick External Catheter for Women because the labeling failed to disclose the presence of dry natural rubber and incorrectly stated the product was latex-free.

    Product
    PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2017·2017-03-22

    Arkon Anesthesia Delivery System Recalled for Unannounced Power Supply Failure

    Del Mar Reynolds Medical is recalling Arkon Anesthesia Delivery Systems because the power supply can fail without triggering normal battery alarms.

    Product
    Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Label

    LeMaitre Vascular is recalling Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2017·2017-03-22

    Maquet Recalls VASOVIEW HEMOPRO VH-3500 Endoscopic Vessel Harvesting System

    Maquet Cardiovascular is recalling 4,283 VASOVIEW HEMOPRO VH-3500 units due to reports of intermittent or no power.

    Product
    VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2017·2017-03-22

    Philips BrightView XCT Nuclear Imaging Systems Recalled for Four Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView XCT nuclear imaging systems worldwide due to four hardware issues, including motion controller failures and door interlock problems.

    Product
    882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2017·2017-03-22

    Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage

    Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use, posing a risk of injury to patients or providers.

    Product
    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1464-2017·2017-03-22

    CareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports

    CareFusion is recalling 1,200 MaxGuard Extension Sets because of reports of separation and leakage between the Y-connector and tubing.

    Product
    MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1398-2017·2017-03-22

    Toshiba Ultimax X-ray generator recalled for premature exposure termination

    Toshiba American Medical Systems is recalling 254 Ultimax DREX-ULT80 X-ray generators because the system may terminate exposure prematurely during an examination.

    Product
    Toshiba Ultimax DREX-ULT80 X-ray generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2017·2017-03-22

    Merge Healthcare iConnect Enterprise Archive Software Recall for Routing Errors

    Merge Healthcare is recalling iConnect Enterprise Archive software versions 5.30.0 through 9.4.3 and V11.0 because routing exceptions may delay diagnosis or treatment.

    Product
    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2017·2017-03-22

    CareFusion Recalls MaxGuard Extension Sets Due to Filter Leaks

    CareFusion is recalling 12,850 MaxGuard Extension Sets because the 0.2 micron filter may leak. These medical devices are used to administer fluids to patients.

    Product
    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may…
    Category
    Medical Device
    Distribution
    Distributed nationwide