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.

21301–21325 of 21633

  • ModerateFDA (Food)·F-2062-2012·2012-09-05

    Hornbacher's French Vanilla Ice Cream Recalled for Missing Egg Labeling

    Cass Clay Creamery is voluntarily recalling Hornbacher's French Vanilla Ice Cream because the packaging fails to list egg as an ingredient, violating FALCPA requirements.

    Product
    HORNBACHERS, FRENCH VANILLA ICE CREAM, Half-gallon (1.89 L), 0 41130 21658 9 (Missing Egg in the Contains statement)
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2264-2012·2012-09-05

    Siemens syngo Imaging XS Software Recall for Miscalculation Defect

    Siemens Medical Solutions is recalling 52 syngo Imaging XS systems due to potential miscalculation of grey scale values in specific image processing functions.

    Product
    syngo Imaging XS. Radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1671-2012·2012-09-05

    Oasis Age Essential Mouthwash Recalled for Microbial Contamination

    Natural Essentials Inc is recalling specific lots of Oasis Age Essential Mouthwash due to contamination with Burkholderia cepacia.

    Product
    Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2105-2012·2012-09-05

    Blount Seafood Recalls Wegman's Tomato Basil Soup Due to Foreign Plastic

    Blount Seafood Corporation is recalling Wegman's Tomato Basil with Orzo Soup because foreign plastic material was found in the retail units.

    Product
    Wegman's Tomato Basil with Orzo Soup 16 oz retail cup Product Code: 85653
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1668-2012·2012-09-05

    Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements

    American Health Packaging is recalling 694 cartons of Mercaptopurine Tablets, USP, 50 mg, because the lot failed USP dissolution test requirements.

    Product
    Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2012·2012-09-05

    Siemens Stratus CS Acute Care D-dimer Calibrator Recall

    Siemens is recalling specific lots of D-dimer Calibrators that may cause instrument calibration errors.

    Product
    Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2012·2012-09-05

    Steris Recalls QKC1692E Quick Connect Devices Due to Labeling Errors

    Steris Corporation is recalling 64 QKC1692E Quick Connect devices because seven endoscope models were not validated for use with the device, requiring label corrections.

    Product
    QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2017-2012·2012-09-05

    SunFresh Natural Fruit & Nut Recalled for Missing Ingredient Labels

    SunFresh Natural is recalling 6-ounce Fruit & Nut packages because the labels fail to list sulfites and FD&C Yellow #6.

    Product
    SunFresh Natural Fruit & Nut, Distributed by: Sunfresh Natural, LLC. Passaic, NJ 07055. Please visit us at: www.sunfreshnatural.com. 6 ounce and 10 ounce packages (Net wt.).
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2104-2012·2012-09-05

    Jakes Spice Drop Recalled for Undeclared Food Dyes

    Four Brothers Packaging is recalling Jakes Spice Drop packages due to undeclared food dyes found by New York State.

    Product
    Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48237 248-747-2223
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2041-2012·2012-09-05

    Cass-Clay Bubble Gum Ice Cream Recalled for Undeclared Dyes

    Cass-Clay Creamery is voluntarily recalling 3-gallon containers of Bubble Gum ice cream because they may contain undeclared food dyes Red 40, Blue 1, and Blue 2.

    Product
    CASS-CLAY, BUBBLE GUM, 3 GALLON (11.34 L).
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2300-2012·2012-09-05

    SRI Surgical Recalls Disposable Accessory Packs Due to Labeling Error

    SRI Surgical is recalling 802,135 disposable accessory packs distributed nationwide because they did not meet specifications due to a labeling error.

    Product
    Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2109-2012·2012-09-05

    Nha Trang Seafoods Recalls Frozen T&T Pangasius Fish Due to Nitrofuran Residue

    Nha Trang Seafoods, Inc. is recalling 2,529 cartons of frozen T&T Pangasius fish because nitrofuran residue was detected. The product was distributed to one consignee in California.

    Product
    Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x 2 per carton: 8/10 oz and 10 oz/up c. 2lbs x 5 per carton: 2/3 oz d. 15lbs carton: 2/3 oz Product labeling reads in part:" T&T SWAI ROSE…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2275-2012·2012-09-05

    Siemens syngo.plaza Radiological Image Processing System Recalled for Miscalculation

    Siemens Medical Solutions is recalling 14 syngo.plaza systems due to a potential miscalculation in images with pixel depth values greater than 12 bits.

    Product
    syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2270-2012·2012-09-05

    Sunquest Laboratory Software Recall for Microbiology Data Entry Errors

    Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4 and later due to potential errors in specimen data entry.

    Product
    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2012·2012-09-05

    Toshiba MRI Systems Recalled for Sequence Queue Status Display Error

    Toshiba American Medical Systems is recalling 54 EXCELART MRI systems because the status display in the sequence queue window may fail to update from 'Current' to 'Done'.

    Product
    EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2282-2012·2012-09-05

    Toshiba Whole Body X-ray Scanner Recalled for Incorrect Data Display

    Toshiba is recalling 24 whole body X-ray scanners because incorrect couch positions and scan times may be displayed on reconstructed images.

    Product
    Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1664-2012·2012-09-05

    Eco-Dent Mouth Rinse Recalled for Bacterial Contamination

    Capco Custom Packaging is recalling Eco-Dent Sparkling Clean Mint mouth rinse due to contamination with Sphingomonas paucimobilis bacteria.

    Product
    Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1660-2012·2012-09-05

    Galderma Recalls Subpotent Capex Shampoo Due to Low Fluocinolone Acetonide Levels

    Galderma is recalling 17,160 bottles of Capex Shampoo because the fluocinolone acetonide content is subpotent. The product was distributed nationwide and in Puerto Rico.

    Product
    Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2043-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Yellow #5 Dye

    Cass Clay Creamery is voluntarily recalling New York Cherry Ice Cream because it may contain undeclared Yellow #5 dye.

    Product
    CASS CLAY, NEW YORK CHERRY ICE CREAM, 3 GALLON (11.34 L).
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2302-2012·2012-09-05

    Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Expired Labeling

    Encore Medical is recalling 7 units of 3DKnee e+ Tibial Inserts because shelf life labeling was incorrect and the components were expired.

    Product
    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This…
    Category
    Medical Device
    Distribution
    0 states