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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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

25876–25900 of 27722

  • SevereFDA (Devices)·Z-0085-2014·2013-11-13

    Baylis Medical Recalls TorFlex Transseptal Guiding Sheath Kits

    Baylis Medical is recalling TorFlex Transseptal Guiding Sheath Kits because the sheath may remove particulate from the dilator, which could migrate into a patient's bloodstream.

    Product
    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0160-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Visual Particulate in Ampules

    Smiths Medical ASD, Inc. is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulates

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulates were found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2014·2013-11-13

    Elekta Recalls Stereotactic Circular Collimators Due to Potential Clinical Errors

    Elekta, Inc. is recalling 89 Stereotactic Circular Collimators used in radiotherapy for head tumors due to a potential for clinical errors.

    Product
    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2014·2013-11-13

    Fresenius Liberty Cycler Recalled for Fluid Leak and Contamination Risk

    Fresenius Medical Care is recalling Liberty Cyclers because fluid leaks may contaminate dialysate, potentially causing peritonitis.

    Product
    Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2014·2013-11-13

    Steris Harmony Equipment Management System Recalled for Drive Screw Failure Risk

    Steris Corporation is recalling 127 Harmony Equipment Management Systems because a drive screw in the ceiling supply unit may break, causing the adjustable arm to drop.

    Product
    Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2014·2013-11-13

    Hamilton Medical Recalls HAMILTON-C2 Ventilators Due to Loudspeaker Defects

    Hamilton Medical is recalling 316 HAMILTON-C2 ventilators because the alarm system loudspeakers exceeded manufacturer-defined limits for improper functioning.

    Product
    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2014·2013-11-13

    Edwards Lifesciences Recalls Aortic Perfusion Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of aortic perfusion cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 1,248 units of Adjustable Gastric Bands because they failed to meet Force to Lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2014·2013-11-13

    Roche COBAS INTEGRA 800 Analyzer Recalled for Software Maintenance Defect

    Roche Diagnostics is recalling 527 COBAS INTEGRA 800 Analyzers with software version 9864.C2 because the system fails to perform necessary ISE service actions and maintenance requests.

    Product
    COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2014·2013-11-13

    Invacare Aquatec Ocean Mobile Shower and Toilet Commode Recall

    Invacare is recalling Aquatec Ocean mobile shower and toilet commodes because backrest cushion fixtures may unlatch in reclined or tilted positions.

    Product
    Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0143-2014·2013-11-13

    Baxter Recalls Dual Luer Lock Caps Due to Loose Particulate Matter

    Baxter Healthcare is recalling specific lots of Dual Luer Lock Caps because loose particulate matter was found in the packaging, posing a risk of embolic events.

    Product
    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2014·2013-11-13

    Intuitive Surgical Recalls da Vinci Patient Carts Due to Fluid Complaints

    Intuitive Surgical is recalling 1,754 da Vinci S and SI Patient Carts worldwide due to increased complaints about fluid entering the cart base.

    Product
    Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0149-2014·2013-11-13

    Ethicon Endo-Surgery Recalls Adjustable Gastric Bands Due to Locking Failure

    Ethicon Endo-Surgery Inc is recalling adjustable gastric bands because they failed to meet force-to-lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2014·2013-11-13

    Vital Images Recalls VitreaCore Software Due to Image Orientation Defect

    Vital Images, Inc. is recalling VitreaCore software versions 6.0 through 6.5 due to a potential for incorrect or reversed image orientation in certain snapshots.

    Product
    VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2014·2013-11-13

    Siemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Phenobarbital Assay because they may produce imprecise results. The recall covers units distributed in the US and Mexico.

    Product
    Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2014·2013-11-13

    Mesa Laboratories Recalls pH 7.0 Buffer Solution Due to Mold Growth

    Mesa Laboratories is recalling specific lots of pH 7.0 Buffer Solution bottles because of mold growth. The product is used to calibrate pH meters in hemodialysis settings.

    Product
    pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2014·2013-11-13

    Stryker Recalls Dekompressor Percutaneous Discectomy Probes Due to Fracture Risk

    Stryker is recalling Dekompressor Percutaneous Discectomy Probes because the auger or cannula may fracture if the device is manually bent, potentially requiring additional medical intervention.

    Product
    Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2014·2013-11-13

    Sorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction

    Sorin Group is recalling 84 S5 Heart-Lung Machines because of a malfunction in the cardioplegia control system.

    Product
    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0171-2014·2013-11-13

    Handicare Bath Bliss Handset Recall for Inoperable Lifts

    Handicare Accessibility is recalling 3,301 handsets for Minivator Bath Bliss Reclining Bath Lifts because two units became inoperable while users were in the tub.

    Product
    Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2014·2013-11-13

    Portex Spinal Trays Recalled Due to Visual Particulate in Lidocaine Ampules

    Smiths Medical ASD is recalling 73 Portex Spinal Trays because visual particulate was found in the included Lidocaine HCL ampules.

    Product
    Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2014·2013-11-13

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers

    Beckman Coulter is recalling 1,025 UniCel DxH 800 and DxH 600 hematology analyzers because specific check valves may fail, potentially causing air or liquid leaks.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2014·2013-11-13

    Siemens Fluoroscopic X-Ray Systems Recalled for Potential Radiation Malfunction

    Siemens is recalling 23 fluoroscopic X-ray systems due to a potential malfunction that may cause radiation to continue longer than expected, resulting in unnecessary dose.

    Product
    Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical ASD, Inc. is recalling Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide