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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19776–19800 of 27682

  • HighFDA (Devices)·Z-1798-2017·2017-04-19

    Windstone Medical Setup Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 500 Setup Packs containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.

    Product
    Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2017·2017-04-19

    Roche Recalls Cobas 8100 Reformatter Modules Due to Rack Crash Risk

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a rack crash can cause sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1819-2017·2017-04-19

    Intuitive Surgical Recalls da Vinci Xi Suction Irrigator Instruments

    Intuitive Surgical is recalling 90 da Vinci Xi Suction Irrigator instruments due to unexpected arm motion with specific software.

    Product
    da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1793-2017·2017-04-19

    Windstone Medical Minor Operation Kit Recall Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 700 Minor Operation Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

    Product
    Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2017·2017-04-19

    RayStation Radiation Therapy Software Recalled for GPU Driver Error

    RaySearch Laboratories is recalling RayStation software due to a potential calculation error in non-standard Citrix environments.

    Product
    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2017·2017-04-19

    Windstone Medical Recalls Ortho Basic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Ortho Basic Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2017·2017-04-19

    Windstone Medical Recalls Custom Kits with Compromised Sterile Eye Pad Packaging

    Windstone Medical Packaging is recalling 164 custom kits containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.

    Product
    Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 Accessory Packages with Non-Sterile Sheaths

    ConMed is recalling Hyfrecator 2000 accessory packages because they contained non-sterile handpiece sheaths labeled as sterile.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2017·2017-04-19

    Windstone Medical Packaging Recalls Plastic Packs with Compromised Sterile Eye Pads

    Windstone Medical Packaging is recalling 376 plastic kits containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.

    Product
    Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2017·2017-04-19

    Windstone Medical Packaging Recalls Cataract Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1770-2017·2017-04-19

    Siemens Combi Dockable Neurosurgery Table Recalled for Height Drop Risk

    Siemens Medical Solutions is recalling three Combi Dockable Neurosurgery tables for MRI systems due to a potential manufacturing error that could cause a sudden drop in table height.

    Product
    Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1816-2017·2017-04-19

    Hill-Rom TotalCare Bed Systems Recalled for Alarm Malfunction

    Hill-Rom is recalling TotalCare Bed Systems because the exit alarm may fail if armed for over 72 hours without triggering.

    Product
    TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2017·2017-04-19

    GE Healthcare Recalls Vivid Ultrasound Systems Due to Patient Selection Error

    GE Healthcare is recalling Vivid E95, E90, and E80 ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.

    Product
    Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1772-2017·2017-04-19

    Draeger Medical Systems Recalls Delta Patient Monitors Due to Low Oxygen Alarm Failure

    Draeger Medical Systems is recalling Delta patient monitors used with Scio gas modules because the low oxygen alarm may fail to sound when oxygen levels drop below the set limit.

    Product
    Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1800-2017·2017-04-19

    Windstone Medical Vitrectomy Packs Recalled for Sterile Packaging Compromise

    Windstone Medical Packaging is recalling 100 Vitrectomy Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2017·2017-04-19

    Merge Hemo software recall for incorrect FFR results display

    Merge Healthcare is recalling Merge Hemo software versions 9.10.0 through 9.40.0 because they may display incorrect Fractional Flow Reserve values during cardiac catheterization.

    Product
    Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2017·2017-04-19

    Windstone Medical Eye Pack Recall Due to Sterile Packaging Compromise

    Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2017·2017-04-19

    Windstone Medical Recalls Dr. Wischmeier Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,170 Dr. Wischmeier Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2017·2017-04-19

    BioMerieux Recalls VIDAS Estradiol II Assay Due to Fulvestrant Cross-Reactivity

    BioMerieux SA is recalling VIDAS Estradiol II kits because Fulvestrant treatment can cause falsely elevated estradiol results.

    Product
    VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2017·2017-04-19

    Windstone Medical Recalls Dicken Eye Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 172 Dicken Eye Packs because the sterile packaging of the eye pads may be compromised.

    Product
    Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2017·2017-04-19

    Windstone Medical Ophthalmic Packs Recalled for Sterile Packaging Compromise

    Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.

    Product
    Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2017·2017-04-19

    Windstone Medical Vitrectomy Kits Recalled for Sterile Packaging Compromise

    Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

    Product
    Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2017·2017-04-19

    ConMed Recalls Sterile Handpiece Sheaths Packaged in Error

    ConMed is recalling sterile handpiece sheaths that were packaged in error with non-sterile units. The mislabeling could lead to the use of non-sterile sheaths.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2017·2017-04-19

    Windstone Medical Recalls Cataract Kits Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2017·2017-04-19

    ConMed Recalls Sterile Handpiece Sheaths Packaged as Non-Sterile

    ConMed is recalling sterile handpiece sheaths that were incorrectly packaged with non-sterile units. This error could lead to the use of non-sterile sheaths in medical procedures.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED…
    Category
    Medical Device
    Distribution
    Distributed nationwide