The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

20601–20625 of 21633

  • 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 (Drugs)·D-261-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination

    Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    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 (Food)·F-1332-2013·2013-04-24

    Trader Joe's Spicy Hummus Dip Recalled for Foreign Material

    Two Chefs on a Roll is recalling Trader Joe's Spicy Hummus Dip because it may contain small pieces of food grade equipment material.

    Product
    Trader Joe's Spicy Hummus Dip 7 oz., 24 units/case, SKU 38056.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-260-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination

    Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after opening. The recall covers 10,121 bottles distributed nationwide and in Puerto Rico.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-255-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination

    Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong chemical odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Drugs)·D-254-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination

    Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after opening. Consumers should stop using the affected products.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1333-2013·2013-04-24

    Two Chefs On A Roll Recalls Trader Joe's Roasted Garlic Hummus Dip

    Two Chefs On A Roll is recalling Trader Joe's Roasted Garlic Hummus Dip because it may contain small pieces of food-grade equipment material.

    Product
    Trader Joe's Roasted Garlic Hummus Dip 7 oz., 24 units/case, SKU 20648.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1318-2013·2013-04-24

    Cypress Grove Humboldt Fog Goat Cheese Recalled for Incorrect Ingredient Labeling

    DPI Specialty Foods is recalling Cypress Grove Humboldt Fog Goat Cheese because it was labeled as containing cultured raw cow's milk instead of pasteurized goat milk.

    Product
    Humboldt Fog (brand) Cypress Grove Chevre, Aged Goat Milk Cheese. Packaged in 7oz (random weight) and 5 oz (random weight). Cypress Grove Chevre # 213146 7oz (random weight) Cypress Grove Chevre # 35363 5oz (random weight) Products are random (various) weight.…
    Category
    Food
    Distribution
    1 state
  • 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 (Drugs)·D-253-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination

    Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1327-2013·2013-04-24

    L. K. Bowman Recalls Canned Mushrooms Due to Isolated Spoilage

    L. K. Bowman is recalling 3,480 #10 cans of Brights mushrooms due to isolated spoilage. The product was distributed to one firm in Utah.

    Product
    Canned mushrooms, #10 cans (Brites, not labeled)
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-1331-2013·2013-04-24

    Trader Joe's Mediterranean Hummus Recalled for Foreign Material

    Two Chefs on a Roll is recalling Trader Joe's Mediterranean Hummus because it may contain small pieces of food-grade equipment material.

    Product
    Trader Joe's Mediterranean Hummus 16 oz., 12 units/case, SKU 90642.
    Category
    Food
    Distribution
    5 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
  • ModerateNHTSA·13V156000·2013-04-23

    Triple E Recalls 2012-2013 Libero, Regency, and Unity RVs for Lighting Defect

    Triple E Recreational Vehicles is recalling 410 model year 2012-2013 Libero, Regency GT, and Unity units because the license plate light does not adequately illuminate the plate at night.

    Product
    REGENCY GT — REGENCY GT, SERENITY, UNITY GT27S, S24CB, GT28D, U24MB
    Category
    Vehicle
    Distribution
    Distributed nationwide