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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31851–31875 of 40325

  • ModerateFDA (Devices)·Z-2774-2015·2015-09-23

    Advanced Sterilization Products Recalls CIDEX OPA Solution for Rinsing Labeling

    Advanced Sterilization Products is reminding customers to follow rinsing instructions for CIDEX OPA Solution to ensure proper disinfection of medical devices.

    Product
    CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2760-2015·2015-09-23

    Biomet 3i Recalls Mislabelled UCLA Dental Abutment Cylinders

    Biomet 3i is recalling 61 UCLA Abutment Hexed Castable Cylinders because they were mislabeled as a different model. The error affects one specific lot distributed worldwide.

    Product
    UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2785-2015·2015-09-23

    RayStation Radiation Therapy Software Recalled for Display Errors

    RaySearch Laboratories is recalling RayStation software due to a floating-point precision error that affects the display of isodose lines and color tables.

    Product
    Radiation Therapy Treatment Planning System software 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 the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2776-2015·2015-09-23

    Edwards Pressure Monitoring Kit Recalled for Flow Restriction Issues

    Edwards Lifesciences is recalling pressure monitoring kits due to flow restriction in the IV set, which may prevent system priming or line flushing.

    Product
    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2764-2015·2015-09-23

    Pointe Scientific autoHDL Reagent Recalled Due to Potential Crystals

    Pointe Scientific is recalling autoHDL Reagent H7545 because crystals may be present in the R1 reagent, potentially resulting from freezing during transport.

    Product
    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits…
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-2779-2015·2015-09-23

    Leica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect

    Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.

    Product
    The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Devices)·Z-2773-2015·2015-09-23

    Pointe Scientific Creatinine Reagent Recall Due to Labeling Error

    Pointe Scientific is recalling 93 kits of Creatinine Reagent C7539-150 because the R1 and R2 reagent bottles are mislabeled, which prevents valid test results.

    Product
    Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2485-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2754-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers

    Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2484-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2750-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Maryland Dissector Instruments

    Intuitive Surgical is recalling 8,217 Maryland Dissector instruments used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2752-2015·2015-09-16

    Intuitive Surgical Recalls Cadiere Forceps for da Vinci Si System

    Intuitive Surgical is recalling Cadiere Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.

    Product
    Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2742-2015·2015-09-16

    Terumo CDI 500 Blood Parameter Monitoring System Recalled for Inaccurate Readings

    Terumo is recalling 4,638 CDI 500 Blood Parameter Monitoring Systems worldwide due to inaccurate readings of vital blood parameters following a software upgrade to version 1.69.

    Product
    CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2746-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup Recalled

    Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2015·2015-09-16

    Medtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance

    Medtronic Perfusion Systems is recalling Hemocor Hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2015·2015-09-16

    Intuitive Surgical Recalls Fenestrated Bipolar Forceps for da Vinci System

    Intuitive Surgical is recalling 21,684 Fenestrated Bipolar Forceps used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Needle Drivers

    Intuitive Surgical is recalling 89 da Vinci Si Single-Site Needle Drivers because the jaws may become fixed in a closed position.

    Product
    Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2015·2015-09-16

    Intuitive Surgical Recalls Curved Needle Drivers for da Vinci System

    Intuitive Surgical is recalling 3,698 Curved Needle Drivers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2751-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers

    Intuitive Surgical is recalling 17,617 da Vinci Si Single-Site Clip Appliers because the jaws may become fixed in a closed position during use.

    Product
    Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Femoral Head Recall

    Smith & Nephew is recalling 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates higher than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2741-2015·2015-09-16

    Siemens Recalls Dimension CREA Tests for Falsely Depressed Results

    Siemens Healthcare Diagnostics is recalling Dimension CREA and Dimension Vista CREA tests because they may produce falsely depressed creatinine results in the presence of hemolysis.

    Product
    Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2747-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Dysplasia Cup Recall

    Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2015·2015-09-16

    Trilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions

    Trilliant Surgical Ltd. is recalling 108 units of Gridlock Screw Driver Bits because they are out of specification, which may cause screw heads to strip during surgery.

    Product
    2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2748-2015·2015-09-16

    Elcam Medical stopcock recall due to punctured blister packages

    Elcam Medical is recalling stopcocks because punctured blister packages were found during manufacturing, creating a potential for device contamination.

    Product
    Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2755-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Crocodile Graspers

    Intuitive Surgical is recalling 15,834 da Vinci Si Single-Site Crocodile Graspers because the instrument jaws may become fixed in a closed position.

    Product
    Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide