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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26801–26825 of 27681

  • HighFDA (Devices)·Z-0766-2013·2013-02-13

    Tobii P10 Battery Box Recalled for Smoke and Chemical Smell During Recharging

    Tobii Assistive Technology is recalling 483 P10 battery boxes that malfunctioned while recharging, producing smoke and a chemical smell.

    Product
    P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.

    Product
    Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2013·2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling 80 breast biopsy trays because they may contain particulate matter in the pharmaceuticals used for injection.

    Product
    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2013·2013-02-13

    Winco Cozy Comfort Premier Recliner 5580 Recalled for Fire Safety Non-Compliance

    Winco Mfg. is recalling 95 Cozy Comfort Premier Recliner 5580 units because the foam and vinyl chemicals do not consistently meet California TB 133 fire protection mandates.

    Product
    Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2013·2013-02-13

    Anspach Effort Recalls Bearing Sleeve Devices Due to Metal Fragment Risk

    The Anspach Effort, Inc. is recalling 8 MA-15C Bearing Sleeve devices distributed in Massachusetts. The recall addresses a risk of metal fragments remaining in the surgical site.

    Product
    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0791-2013·2013-02-13

    Medacta Quadra Trial Broach size 0 recalled due to tip breakage

    Medacta USA Inc. is recalling 26 units of the Quadra Trial Broach size 0 because the tip broke during surgery.

    Product
    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2013·2013-02-13

    Lansinoh Thera Pearl Breast Therapy Hot and Cold Packs Recalled for Overheating Risk

    Lansinoh is recalling Thera Pearl 3-in-1 Breast Therapy packs because incorrect Spanish heating instructions may cause the product to overheat.

    Product
    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.

    Product
    Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2013·2013-02-13

    Invacare Solara 3G Manual Wheelchair Recalled for Brake Failure Risk

    Invacare is recalling three Solara 3G custom manual wheelchairs because the wheels may rotate freely despite the hub brake being engaged.

    Product
    Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2013·2013-02-13

    Oxus Portable Oxygen Concentrator Li-Ion Battery Recall

    Oxus America is recalling 1,724 Li-Ion batteries for the RS-00400 Portable Oxygen Concentrator due to potential over-discharge damage to cells.

    Product
    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-0754-2013·2013-02-06

    GE AdvantageSim MD Software Recall for Incorrect Series Labeling

    GE Healthcare is recalling AdvantageSim MD versions 7.4 through 7.6 because incorrect series labeling may lead to under-treatment of tumors.

    Product
    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0741-2013·2013-02-06

    Hamilton T1 Ventilator Recall for Pediatric Software Calculation Error

    Hamilton Medical Inc is recalling 97 Hamilton T1 ventilators with software versions 1.1.2 or lower due to a calculation error affecting oxygen consumption estimates for small pediatric patients.

    Product
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2013·2013-02-06

    Ethicon ENSEAL G2 Tissue Sealers Recalled for Potential Self-Activation

    Ethicon Endo-Surgery Inc. is recalling ENSEAL G2 Tissue Sealers because they may self-activate during use, causing unintended thermal damage.

    Product
    Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0760-2013·2013-02-06

    Varian Medical Systems Recalls Titanium Rectal Retractors for Brachytherapy

    Varian Medical Systems is recalling 152 titanium rectal retractors used in brachytherapy due to potential contamination risks that could cause infections, toxicity, or allergic reactions.

    Product
    Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2013·2013-02-06

    Cordis ExoSeal Vascular Closure Device Recalled for Sterility Assurance Failure

    Cordis is recalling ExoSeal Vascular Closure Devices because the sterilization process did not meet required sterility assurance levels.

    Product
    Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2013·2013-02-06

    Varian Medical Rectal Retractors Recalled for Contamination Risk

    Varian Medical Systems is recalling stainless steel rectal retractors used in brachytherapy due to potential contamination that could cause infections, toxicity, or allergic reactions.

    Product
    Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2013·2013-02-06

    Extremity Medical Recalls IO FiX System Screw Measuring Device

    Extremity Medical LLC is recalling 93 units of the IO FiX System Accessory screw measuring device because it may measure screw length approximately 5 mm short, potentially leading to the selection of an inappropriate implant size.

    Product
    Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2013·2013-02-06

    BD Vacutainer Citrate Blood Collection Tubes Recalled for Test Errors

    Becton Dickinson is recalling specific blood collection tubes due to reports of extended Partial Thromboplastin Time (aPTT) test results.

    Product
    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2013·2013-02-06

    Mindray Recalls DPM5 Monitors Due to Missing ST and Arrhythmia Features

    Mindray is recalling 13 DPM5 vital signs monitors because ST and Arrhythmia features may not be available.

    Product
    Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2013·2013-02-06

    Motorola Laser Utility Products Recalled for Incorrect Laser Power Settings

    Motorola Inc is recalling PCS3000/CS3070 laser utility products because they were manufactured with Class 2 laser power settings instead of the specified Class 1 levels.

    Product
    Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2013·2013-02-06

    Roche COBAS TaqMan MTB Test Definition Files Recalled for False Negative Risk

    Roche is recalling COBAS TaqMan MTB Test Definition Files due to an incorrect cutoff value that may cause false negative results for tuberculosis tests.

    Product
    COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0757-2013·2013-02-06

    Abbott Vascular Recalls RX Accunet Embolic Protection System Lots

    Abbott Vascular is recalling specific lots of the RX Accunet Embolic Protection System because the peel-away sheath may be difficult to remove due to higher than normal wall thickness.

    Product
    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0712-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation

    DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0705-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screw Recall for Potential Separation

    DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0708-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screw Recall for Potential Disassociation

    DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide