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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38626–38650 of 40449

  • ModerateFDA (Devices)·Z-1108-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because extension springs may be out of specification, potentially causing imprecise chemistry test results.

    Product
    VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2013·2013-04-24

    Horiba ABX PENTRA 400 I.S.E. Module Recalled for Missing Linearity Flags

    Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.

    Product
    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1110-2013·2013-04-24

    Intuitive Surgical da Vinci System User Manual Recall for Sterile Adapter Instructions

    Intuitive Surgical is recalling IS3000 user manuals for da Vinci Si and Si-e systems to provide revised instructions for sterile adapter engagement and instrument installation.

    Product
    IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2013·2013-04-24

    Intuitive Surgical Recalls da Vinci S User Manual for Sterile Adapter Instructions

    Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.

    Product
    IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2013·2013-04-24

    Abbott Recalls Phenobarbital Reagent Lots Due to Imprecision Issues

    Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.

    Product
    Clinical Chemistry Phenobarbital, list number 1E08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2013·2013-04-24

    Toshiba Diagnostic Ultrasound Systems Recalled for Startup Issues

    Toshiba is recalling 233 Aplio 500/400/300 diagnostic ultrasound systems due to startup issues that may cause system damage.

    Product
    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1106-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.

    Product
    VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2013·2013-04-24

    Nipro TRUEtrack Blood Glucose Monitor Kits Recalled for Labeling Error

    Nipro Diagnostics is recalling 1,627 TRUEtrack monitor kits because the outer boxes state an incorrect storage temperature range for the test strips.

    Product
    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1003-2013·2013-04-24

    Philips Healthcare Recalls CT Systems Due to Inaccurate Dose Measurements

    Philips Healthcare is recalling CT systems because CTDI measurements were 15 to 25% higher than protocol parameters.

    Product
    Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2013·2013-04-24

    Alere Cholestech LDX ALT AST Test Cassette Recalled for Humidity Impact

    Alere San Diego is recalling 38,571 ALT AST test cassettes because humidity changes may impact test results.

    Product
    Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1121-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1020-2013·2013-04-24

    DeGotzen XGenus Dental X-ray Units Recalled for Labeling Defects

    DeGotzen is recalling 159 XGenus dental X-ray units because method samples failed labeling and certification requirements.

    Product
    DeGotzen XRay unit XGenus Dental X-ray unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2013·2013-04-24

    Synvasive Oxford Partial Knee Resection Blades Recalled for Incorrect Component

    Synvasive Technology is recalling 100 kits of Oxford Partial Knee Resection Procedure 3 Packs because they contained the incorrect surgical blade.

    Product
    The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2013·2013-04-24

    Vital Images Recalls Vitrea CT Cardiac Analysis Software Due to Data Errors

    Vital Images is correcting a defect in the Vitrea CT Multi-Chamber Cardiac Functional Analysis application where numerical values in the Results Table may be incorrect.

    Product
    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1129-2013·2013-04-24

    LifeScan OneTouch Ultra Control Solution Recalled for Potential Meter Readings

    LifeScan Inc is recalling OneTouch Ultra Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.

    Product
    LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1130-2013·2013-04-24

    LifeScan OneTouch Select Control Solution Recalled for Potential Meter Readings

    Lifescan Inc is recalling OneTouch Select Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.

    Product
    LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2013·2013-04-24

    Smith & Nephew Recalls Trigen Bone Screws Due to Incorrect Coating

    Smith & Nephew is recalling 23 units of 4.5 mm Trigen bone screws that were incorrectly anodized with a gold coating instead of gray.

    Product
    TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2013·2013-04-24

    Synvasive Reciprocating Saw Blades Recalled for Labeling Errors

    Synvasive Technology is recalling 3,442 reciprocating saw blades due to incorrect labeling regarding blade type, expiration dates, and compatible power systems.

    Product
    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2013·2013-04-24

    Bacterin OsteoSelect DBM Putty Recalled for Unvalidated Testing Procedure

    Bacterin International is recalling 165 units of OsteoSelect DBM Putty because the firm's retesting procedure was not validated.

    Product
    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2013·2013-04-24

    Integra XKnife Software Versions 5.0.1 and 5.0.2 Recalled for Beam Plan Error

    Integra LifeSciences Corp. is recalling XKnife software versions 5.0.1 and 5.0.2 due to a software error that may occur when transmitting beam plans.

    Product
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1146-2013·2013-04-24

    Edwards Lifesciences Recalls Pressure Monitoring Sets with VAMP Plus System

    Edwards Lifesciences is recalling Pressure Monitoring sets with VAMP Plus closed blood sampling systems due to incorrect assembly that may dilute blood samples.

    Product
    Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide