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.

20901–20925 of 21633

  • ModerateFDA (Devices)·Z-0558-2013·2012-12-26

    Integra LifeSciences Recalls Mayfield Composite Series Base Units

    Integra LifeSciences is recalling Mayfield Composite Series Base Units and Skull Clamps due to performance issues that could impact functionality.

    Product
    MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0604-2013·2012-12-26

    Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0528-2013·2012-12-26

    Mindray Recalls V Series Patient Monitors Due to Touchscreen Malfunction

    Mindray is recalling V Series patient monitors because the touchscreens may stop responding to touch.

    Product
    Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0490-2013·2012-12-19

    Roche Recalls COBAS INTEGRA 400 Analyzer Software Due to Diagnostic Issue

    Roche Molecular Systems is recalling 855 COBAS INTEGRA 400/400 plus systems due to a device-associated diagnostic software issue.

    Product
    The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0485-2013·2012-12-19

    Roche MagNA Pure LC Software Recall for Diagnostic Issue

    Roche Molecular Systems is recalling 816 MagNA Pure LC instruments due to a device-associated diagnostic software issue.

    Product
    The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2013·2012-12-19

    Voluntary Recall of Specific Lots of TENS Electrodes Due to Manufacturing Exposure

    Covidien is voluntarily recalling specific lots of TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.

    Product
    Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0493-2013·2012-12-19

    Roche DataCare POC Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling 126 units of DataCare POC software due to a device-associated diagnostic issue.

    Product
    DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0508-2013·2012-12-19

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur CA 19-9 assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0518-2013·2012-12-19

    Quasar Bio-Tech Recalls Unapproved Infrared LED Lamps and Accessories

    Quasar Bio-Tech is recalling the Quasar MD and other infrared LED devices because they are unapproved for marketing in the United States.

    Product
    Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0821-2013·2012-12-19

    Ella's Kitchen Recalls Milk and Vanilla Baby Cookies Due to Mold

    Ella's Kitchen is recalling 26,400 units of milk and vanilla baby cookies because they may contain mold. Consumers should stop eating the product and return it to the store.

    Product
    Ella's Kitchen yum yummy milk + vanilla baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000526 packaged in a chipboard carton with 12 cookies per box
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0521-2013·2012-12-19

    Leica TdT Staining Reagent Recalled for Stability Issues

    Leica Microsystems is recalling 322 vials of Novocastra TdT Staining Reagent because the product is not stable up to its expiry date, affecting staining intensity.

    Product
    Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No.…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0484-2013·2012-12-19

    Roche Data Station AMPLILINK Software Recalled for Device-Associated Issue

    Roche Molecular Systems is recalling Data Station AMPLILINK software due to a device-associated diagnostic software issue. The software is used with various COBAS instruments for molecular diagnostics.

    Product
    Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0483-2013·2012-12-19

    Hospira Recalls Plum A+ Infusion Pumps Due to Volume Knob Defect

    Hospira is recalling Plum A+ infusion pumps because the volume control knob may reverse the alarm volume direction.

    Product
    Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2013·2012-12-19

    ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues

    ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.

    Product
    WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0502-2013·2012-12-19

    ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues

    ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.

    Product
    WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0512-2013·2012-12-19

    Siemens Healthcare Recalls ADVIA Centaur Theophylline 2 Assay Kits

    Siemens Healthcare is recalling ADVIA Centaur Theophylline 2 assay kits because room temperature changes may affect test results.

    Product
    Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0486-2013·2012-12-19

    Roche MagNA Pure 96 System Software Recall

    Roche Molecular Systems is recalling 13 MagNA Pure 96 Systems due to a device-associated diagnostic software issue.

    Product
    The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0492-2013·2012-12-19

    Roche DataCara GM Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling DataCara GM software due to a device-associated diagnostic issue. 479 units were distributed nationwide.

    Product
    DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2013·2012-12-19

    Siemens ADVIA Centaur Folate Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur Folate assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0510-2013·2012-12-19

    Siemens ADVIA Centaur Digitoxin Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur Digitoxin tests because room temperature changes may affect assay results.

    Product
    Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0806-2013·2012-12-19

    Unified Grogers Recalls Pure Apricot Pecan Flats for Undeclared Sulfites

    Unified Grocers is recalling Pure Apricot Pecan Flats because the product may contain undeclared sulfites. The recall covers 2,120 units distributed in California, Alaska, Washington, and Oregon.

    Product
    Pure Apricot Pecan Flats, 10 units/case, 6oz. UPC 8 73376 00303.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0519-2013·2012-12-19

    Quasar Bio-Tech Recalls Unapproved LED Skin Treatment Devices

    Quasar Bio-Tech is recalling specific LED skin treatment devices because they are unapproved by the FDA.

    Product
    Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2013·2012-12-19

    Siemens Healthcare BNP Test Kit Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling BNP test kits because room temperature changes may affect assay results on ADVIA Centaur systems.

    Product
    Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0491-2013·2012-12-19

    Roche DataInnovations Instrument Manager Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling DataInnovations Instrument Manager software due to a device-associated diagnostic software issue.

    Product
    DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0520-2013·2012-12-19

    Advanced Sterilization Products Recalls Sterrad Cyclesure 24 Biological Indicators

    Advanced Sterilization Products is recalling Sterrad Cyclesure 24 Biological Indicators because the manufacturer lacks adequate data to support the full labeled shelf-life.

    Product
    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator.…
    Category
    Medical Device
    Distribution
    Distributed nationwide