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

25551–25575 of 27686

  • HighFDA (Devices)·Z-0748-2014·2014-01-22

    GE Healthcare Recalls Merge Mammo Workstation Software Due to Image Display Errors

    GE Healthcare is recalling 28 units of Merge Mammo software version 8.0.2 because images may display out of sync with the navigator, potentially leading to misdiagnosis.

    Product
    Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT.…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0650-2014·2014-01-15

    Nova Hospital Blood Glucose Meters Recalled for Battery Swelling and Leakage

    Nova Biomedical is recalling hospital blood glucose meters due to battery swelling and cell leakage. The recall covers approximately 200,000 units distributed nationwide.

    Product
    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0654-2014·2014-01-15

    Anspach Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems from the market because the outer hose on the motor hand-piece can rupture without warning if air flow is blocked.

    Product
    ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0683-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula…
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0679-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient…
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0694-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0631-2014·2014-01-15

    Anspach BLACKMAX-N Pneumatic Motor Recalled for CJD Exposure Risk

    The Anspach Effort, Inc. is recalling four BLACKMAX-N pneumatic motors and one Autolube III foot control used in a case involving a patient with Creutzfeldt-Jacob Disease.

    Product
    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0611-2014·2014-01-15

    Puritan Bennett 840 Ventilator Software Recall for Diagnostic Code XB0069

    Covidien is recalling Puritan Bennett 840 ventilators with specific software revisions because a software error causes the device to stop mechanical ventilation.

    Product
    Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0643-2014·2014-01-15

    Smiths Medical Recalls Insulin Syringes With Visible Particulate on Needles

    Smiths Medical ASD, Inc. is recalling 93,700 units of Hypodermic Needle-Pro Fixed Needle Insulin Syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0646-2014·2014-01-15

    Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles

    Smiths Medical is recalling 54,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0704-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0632-2014·2014-01-15

    Anspach Craniotome Recalled After Use in Creutzfeldt-Jakob Disease Case

    The Anspach Effort, Inc. is recalling specific craniotome attachments used in a case involving a patient with Creutzfeldt-Jakob Disease.

    Product
    Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0626-2014·2014-01-15

    Siemens HbA1c Flex Reagent Cartridge Recall for Positive Bias

    Siemens is recalling HbA1c Flex reagent cartridges due to positive bias and frequent out-of-range flags, which may affect diabetes monitoring.

    Product
    HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0705-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0666-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0635-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2014·2014-01-15

    Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles

    Smiths Medical is recalling 108,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave¿, Part No. A1000, Item No. A1078 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0700-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0532-2014·2014-01-15

    Trans American Medical Recalls Spectre Wireless Footswitches Due to Uncommanded X-ray Risk

    Trans American Medical is recalling 68 Spectre Wireless Footswitch/Handswitch units because they may produce uncommanded X-rays.

    Product
    Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0687-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular…
    Category
    Medical Device
    Distribution
    14 states