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.

17776–17800 of 21645

  • ModerateFDA (Devices)·Z-2715-2014·2014-10-08

    Siemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Immunoassay Systems because patient demographic data may be incorrectly merged under rare circumstances.

    Product
    ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2486-2014·2014-10-01

    Dairy Farmers of America Recalls Bulk Cream Due to Sulfamethazine

    Dairy Farmers of America is recalling bulk cream after raw milk tested positive for the drug Sulfamethazine. The product was distributed to facilities in Ohio, Illinois, Missouri, and Michigan.

    Product
    Cream (Bulk; approximately 40,000 pounds per tanker load)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1571-2014·2014-10-01

    Akorn Recalls Rifampin for Injection Due to Impurity Specification Failure

    Akorn, Inc. is recalling 5,539 vials of Rifampin for Injection USP, 600 mg, because a stability test showed an impurity level exceeding specifications.

    Product
    Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2521-2014·2014-10-01

    Purple Corn Drink Recalled for Undeclared Dyes and Unallowable Colorant

    JP Trading and Global Imports LLC is recalling 85 cases of Tradiciones' Andinas Purple Corn Drink Chicha Morada due to undeclared dyes and an unallowable colorant.

    Product
    Tradiciones' Andinas Purple Corn Drink Chicha Morada, Net Wt: 33,81 Fl. oz. (1 Lt.), Distributed by: JP Trading and Global Imports LLc, Newark, NJ 07102 (973) 242-3143, Toll free (888) 606 PERU, NDC 854219002795
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1609-2014·2014-10-01

    Apotex Recalls Olanzapine Tablets Due to Subpotent Drug Levels

    Apotex Corp. is recalling Olanzapine Orally Disintegrating Tablets 5 mg because testing showed the drug levels were below specification.

    Product
    Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2683-2014·2014-10-01

    Nanosphere Recalls Verigene Gram-Positive Blood Culture Test Due to Processing Errors

    Nanosphere is recalling 4,440 units of the Verigene Gram-Positive Blood Culture Nucleic Acid Test because Tip Holder Assemblies caused increased processing errors.

    Product
    The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which…
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2687-2014·2014-10-01

    Beckman Coulter Recalls Sample Probe Cables for Immunoassay Systems

    Beckman Coulter is recalling sample probe cables for UniCel immunoassay systems because nonconforming units may cause delays in reporting test results.

    Product
    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1605-2014·2014-10-01

    Qualitest Recalls Subpotent Methylprednisolone Tablets Due to Stability Issues

    Qualitest Pharmaceuticals is recalling specific lots of Methylprednisolone 4 mg tablets because they may be subpotent due to a 6-month stability time point issue.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2682-2014·2014-10-01

    Nanosphere Recalls Verigene Clostridium difficile Test Due to Processing Errors

    Nanosphere is recalling 80 units of the Verigene Clostridium difficile Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of…
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2708-2014·2014-10-01

    Dako Autostainer Link 48 Software Recall for Reagent Handling Issues

    Dako is recalling software for the Autostainer Link 48 because an upgrade may cause premature reagent rejection or inadequate aspiration if specific maintenance conditions are met.

    Product
    Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2692-2014·2014-10-01

    Horiba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update

    Horiba Medical is recalling ABX PENTRA Magnesium RTU Reagent to update on-board stability claims from 7 days to 1 day.

    Product
    ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2502-2014·2014-10-01

    Phoenix Produce Recalls Chinese Style Noodles for Undeclared Dyes

    Phoenix Produce & Noodle Company is recalling Chinese Style Noodles in Arizona because they contain undeclared FD&C Yellow No. 5, Yellow No. 6, and Red No. 40.

    Product
    Chinese Style Noodles, 10lbs./bx
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2680-2014·2014-10-01

    Siemens Ysio Systems Recalled for Potential Image Artifacts

    Siemens is recalling 62 Ysio Systems due to a software error that may cause line artifacts in images, potentially requiring examinations to be repeated.

    Product
    The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2681-2014·2014-10-01

    Nanosphere Recalls Verigene Gram Negative Blood Culture Test Kits

    Nanosphere is recalling 400 units of the Verigene Gram Negative Blood Culture Nucleic Acid Test due to an increased rate of processing errors caused by tip holder assemblies.

    Product
    The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance…
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Drugs)·D-1608-2014·2014-10-01

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 160,800 Daytrana patches because the adhesive release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2672-2014·2014-10-01

    Vidacare EZ-IO Needle Set Recalled for Specification Failures

    Vidacare Corporation is voluntarily recalling 172 units of EZ-IO 45mm Needle Sets because they do not meet specifications.

    Product
    EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2673-2014·2014-10-01

    Becton Dickinson Recalls BD PosiFlush SF Saline Flush Syringes Due to Open Seals

    Becton Dickinson is recalling 3,088,320 units of BD PosiFlush SF Saline Flush Syringes because some units were found with open seals.

    Product
    BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2514-2014·2014-10-01

    Arise & Shine Bentonite Supplement Recalled for Iron Mislabeling

    Arise & Shine is recalling Hydrated Bentonite dietary supplements because the label incorrectly states 0% Daily Value of iron, while the product actually contains 106%.

    Product
    The product is labeled in part "***Arise & Shine Hydrated Bentonite Dietary Supplement Extra Thick Formula 32 FL OZ ***% Daily Value Iron 0***Distributed by: Arise & Shine Herbal Products 562 Parsons Drive Medford, Oregon 97501***" Product is packaged in a foil pouch with a…
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2513-2014·2014-10-01

    Frito-Lay Recalls Oven Baked Lay's BBQ Crisps Due to Packaging Error

    Frito-Lay is recalling Oven Baked Lay's BBQ flavor crisps because a packaging error added a 'GF' symbol to the packages.

    Product
    Oven Baked Lay's BBQ flavor crisps in 1 1/8 oz package, UPC 2840007189
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2684-2014·2014-10-01

    Nanosphere Recalls Verigene Respiratory Virus Plus Test Due to Processing Errors

    Nanosphere is recalling Verigene Respiratory Virus Plus tests because Tip Holder Assemblies caused increased processing errors on the Processor SP.

    Product
    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with…
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2686-2014·2014-10-01

    Fresenius Naturalyte Liquid Bicarbonate Concentrate Recalled for Temperature Violation

    Fresenius Medical Care is recalling 72 cases of Naturalyte Liquid Bicarbonate Concentrate distributed in Texas because the product was held at temperatures above the recommended storage range.

    Product
    Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2679-2014·2014-10-01

    Instratek Recalls Mini Screw Sets with Faded Markings

    Instratek is recalling 96 Mini Screw Sets and gauges due to faded and incorrect markings on instruments.

    Product
    Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1607-2014·2014-10-01

    Alvogen Recalls Oxycodone and Acetaminophen Tablets Due to Uniformity Failure

    Alvogen, Inc. is recalling 8,964 bottles of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg because the lot failed uniformity of dosage units specifications for the oxycodone component.

    Product
    Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2485-2014·2014-10-01

    Dairy Farmers of America Recalls Condensed Skim Milk for Sulfamethazine

    Dairy Farmers of America is recalling condensed skim milk because raw milk tested positive for the antibiotic sulfamethazine. The product was distributed to facilities in Ohio, Illinois, Missouri, and Michigan.

    Product
    Condensed Skim Milk in bulk tanker (approximately 40,000 pounds per tanker load)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-2488-2014·2014-10-01

    Lakewood Organic Apple Juice Recalled for Inorganic Arsenic Levels

    Florida Bottling, Inc. is recalling Lakewood Organic Apple Juice because it contains inorganic arsenic levels exceeding FDA limits of concern.

    Product
    Lakewood Organic Fresh Pressed GMO Free Pure Apple Cold Pressed Not from Concentrate Juice Fruit 32 FL OZ (1 QT) 946 mL Lakewood Miami, FL 33127
    Category
    Food
    Distribution
    13 states