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.

20926–20950 of 21633

  • ModerateFDA (Devices)·Z-0507-2013·2012-12-19

    Siemens Healthcare Recalls CA 27.29 Assay Kits Due to Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur BR Assay kits for CA 27.29 because room temperature changes can alter test results.

    Product
    Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-091-2013·2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling specific lots of Enjuvia tablets because they failed potency tests. The affected medication may contain less active ingredient than labeled.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0489-2013·2012-12-19

    Roche COBAS 8000 Analyzer Software Recall for Diagnostic Issue

    Roche Molecular Systems is recalling 77 COBAS 8000 modular analyzers nationwide due to a device-associated diagnostic software issue.

    Product
    The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0501-2013·2012-12-19

    Voluntary Recall of Empi STIMC RE Self Adhesive Electrodes

    Covidien is voluntarily recalling specific lots of Empi STIMC RE Self Adhesive electrodes because manufacturing exposure to an employee with a minor cut may have occurred.

    Product
    Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0503-2013·2012-12-19

    ConMed Recalls WANG Transbronchial Aspiration Needles for Fit Issues

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

    Product
    WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0500-2013·2012-12-19

    Voluntary Recall of Performa TENS Electrodes Due to Manufacturing Exposure

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

    Product
    Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0515-2013·2012-12-19

    Siemens MAVIG PORTEGRA 2 Surgical Light Recall for Missing Component

    Siemens is recalling 1,315 MAVIG PORTEGRA 2 surgical lights because a specific component may have been omitted during installation.

    Product
    MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0522-2013·2012-12-19

    Roche Recalls Cobas b 123 Fluid Pack Cuvettes Due to Thickness Defect

    Roche Diagnostics is recalling specific lots of Cobas b 123 Fluid Pack COOX cuvettes because a production error caused a change in layer thickness, leading to a higher failure rate.

    Product
    Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2013·2012-12-19

    Siemens ADVIA Centaur DHEAS Assay Recalled for Temperature Sensitivity

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

    Product
    Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0487-2013·2012-12-19

    Roche LightCycler 1.2 Diagnostic Software Recalled for Device-Associated Issue

    Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.

    Product
    LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F0822-2013·2012-12-19

    Ella's Kitchen Recalls Apple and Ginger Baby Cookies Due to Mold

    Ella's Kitchen is recalling 10,700 units of apple and ginger baby cookies because they may contain mold. The product was distributed nationwide.

    Product
    Ella's Kitchen yum yummy apple + ginger baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000533 packaged in a chipboard carton with 12 cookies per box
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0488-2013·2012-12-19

    Roche Recalls LightCycler 2.0 Instrument Due to Diagnostic Software Issue

    Roche Molecular Systems is recalling 1,213 LightCycler 2.0 instruments due to a device-associated diagnostic software issue.

    Product
    LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0481-2013·2012-12-19

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

    Hospira is recalling Plum A+ single channel infusion pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.

    Product
    Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0513-2013·2012-12-19

    Mindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations

    Mindray DS USA is recalling 124 DPM 6 and 7 patient monitors because specific calculation features may be unavailable.

    Product
    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0517-2013·2012-12-19

    Quasar Bio-Tech Recalls Unapproved Baby Quasar Infrared LED Lamps

    Quasar Bio-Tech is recalling Baby Quasar and Baby Quasar Pink infrared LED lamps because the devices are unapproved by the FDA.

    Product
    Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-090-2013·2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling 5 bottles of Enjuvia tablets due to low assay results. The medication was distributed in Virginia.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-077-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid tablets because they failed to meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-083-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0463-2013·2012-12-12

    Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values

    Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which reduces the standard curve slope.

    Product
    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-080-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.125 mg. Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 1,924,174 tablets of Thyro-Tab 0.125 mg. (Lot #HB27811) because the product does not meet in-process specification requirements.

    Product
    Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-087-2013·2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 20 Due to Defective Delivery System

    Genentech is recalling 10,306 syringes of Nutropin AQ NuSpin 20 because the dose knob may spin slowly, causing delayed injection delivery.

    Product
    Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2013·2012-12-12

    Siemens syngo.plaza Radiological Image Processing System Software Update Recall

    Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.

    Product
    Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-088-2013·2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 10 Due to Defective Delivery System

    Genentech is recalling 12,791 syringes of Nutropin AQ NuSpin 10 because the dose knob may spin slowly, causing delayed injection delivery.

    Product
    Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-076-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.088 mg. Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.8 million Thyro-Tab 0.088 mg. tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-075-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling specific bottles of Levothroid tablets because they failed to meet in-process specification requirements during manufacturing.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide