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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24976–25000 of 27722

  • HighFDA (Devices)·Z-1953-2014·2014-07-09

    Medical Action Industries Recalls Port-A-Cath Trays Due to Seal Defects

    Medical Action Industries is recalling Port-A-Cath Trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1950-2014·2014-07-09

    Medical Action Industries Recalls Sterile Laceration Trays Due to Seal Defects

    Medical Action Industries is recalling sterile laceration trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1957-2014·2014-07-09

    Medical Action Industries Recalls Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling sterile laceration kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1956-2014·2014-07-09

    McKesson Medi-Pak Laceration Trays Recalled for Incomplete Sterile Seals

    Medical Action Industries is recalling 474 cases of McKesson Medi-Pak Laceration Trays because some sterile kits may have incomplete seals that could compromise sterility.

    Product
    McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1822-2014·2014-07-02

    Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1820-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires due to reports of the outer polymer jacket being damaged during use.

    Product
    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1816-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA; Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1815-2014·2014-07-02

    Nitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1819-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1812-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1818-2014·2014-07-02

    Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket can be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1813-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1821-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1814-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1925-2014·2014-07-02

    Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect

    Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.

    Product
    DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2014·2014-07-02

    Zynex IF 8000 Interferential Electrical Stimulation Device Recalled for Overheating

    Zynex Medical is recalling 1,461 IF 8000 devices because a malfunction can cause them to stop working or overheat, posing a burn risk.

    Product
    IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2014·2014-07-02

    Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint

    Intuitive Surgical is recalling 19 units of the IS4000 da Vinci Xi 0 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.

    Product
    IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1859-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling 2,711 cases of dialysate sacks because aluminum levels exceeded internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2014·2014-07-02

    Siemens Healthcare Recalls ADVIA Acid/Base Reagent Kits Due to Metal Contamination

    Siemens Healthcare is recalling ADVIA Acid/Base Reagent 1 and 2 Kits because trace metal contamination caused the acid bottles to swell.

    Product
    Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2014·2014-07-02

    Siemens StreamLAB Analytical Workcell Recalled for Trip and Fall Hazard

    Siemens is recalling 317 StreamLAB Analytical Workcells because protruding pins on the Input/Output Module have contributed to trip and fall incidents.

    Product
    Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL…
    Category
    Medical Device
    Distribution
    Distributed nationwide