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.

18051–18075 of 21645

  • ModerateFDA (Food)·F-2232-2014·2014-08-06

    Purefruit Chile Recalls HyVee Applesauce Pouches Due to Mold Risk

    Purefruit Chile S.A. is recalling specific HyVee applesauce pouches due to the possibility of mold. Consumers should check their pantry for the affected product.

    Product
    HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, "***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2287-2014·2014-08-06

    GM Manufacturing Recalls CKLS Capsules for cGMP Violations

    GM Manufacturing is recalling CKLS capsules due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

    Product
    CKLS, Capsules
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2259-2014·2014-08-06

    GM Manufacturing Recalls Bitter Melon Supplements for cGMP Violations

    GM Manufacturing is recalling 380 units of Bitter Melon dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Bitter Melon, 225cc HDPE Bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2280-2014·2014-08-06

    GM Manufacturing Recalls Stomach & Spleen Plus Dietary Supplements

    GM Manufacturing is recalling Stomach & Spleen Plus dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Stomach & Spleen Plus, Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1501-2014·2014-08-06

    Daiichi Sankyo Recalls Azor Tablets Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 5 bottles of Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg/40 mg because they were not stored at controlled room temperature during shipping.

    Product
    Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2014·2014-08-06

    Nidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label

    Nidek Inc. is recalling 29 MC-500 Multicolor Laser Photocoagulators because the laser aperture label was not affixed to the devices prior to shipment.

    Product
    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2281-2014·2014-08-06

    GM Manufacturing Recalls Bone & Joint Plus Dietary Supplements

    GM Manufacturing is recalling Bone & Joint Plus dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Bone & Joint Plus, Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1507-2014·2014-08-06

    Benicar HCT Tablets Recalled Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 86 bottles of Benicar HCT 40 mg/12.5 mg because they were not stored at controlled room temperature during shipping.

    Product
    Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2134-2014·2014-08-06

    Brainlab Patient Data Manager 2.0 Software Recall for Image Display Defects

    Brainlab AG is recalling Patient Data Manager 2.0 software due to defects in transferring and displaying non-square pixel medical images.

    Product
    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2230-2014·2014-08-06

    Purefruit Chile Recalls Pouched Applesauce Due to Potential Mold

    Purefruit Chile S.A. is recalling fruty U applesauce pouches due to the possibility of mold. The product was distributed to retail stores nationwide.

    Product
    fruty U applesauce, apple; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***fruty U APPLE applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2081-2014·2014-07-30

    AGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction

    AGFA Corp. is recalling 216 DX-D 100 digital radiography systems because liquid contact with the touch screen may cause the device to incorrectly recognize user input and alter settings.

    Product
    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2014·2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling RECLAIM Taper Protector Sleeves because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Food)·F-2221-2014·2014-07-30

    Land O'Lakes American Deli Cheese Recalled for Plastic Contamination

    Land O'Lakes is recalling 5 lb blocks of Premium Deli Cheese, American, due to potential contamination with large pieces of plastic.

    Product
    Item: 48135 Land O'Lakes, Premium Deli Cheese, American, 5 lbs (2.27 KG)
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2087-2014·2014-07-30

    Synthes Orthopedic Guide Blocks Recalled for Incorrect Labeling

    Synthes, Inc. is recalling 180 Guide Blocks for the Volar Distal Radius Plate System due to incorrect package labeling. The physical parts are correctly marked, but the packaging may identify the wrong side.

    Product
    Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2196-2014·2014-07-30

    Country Life Liquid Calcium Magnesium Supplement Recalled for Particulates

    Country Life is recalling specific lots of its liquid calcium and magnesium dietary supplement because the product contains insoluble particulates that do not meet quality standards.

    Product
    Country Life TARGET MINS CALCIUM MAGNESIUM With Vitamin D3 Complex, WILD BLUEBERRY FLAVOR, LIQUID Dietary Supplement, 16 FL. OZ. (1 PINT) (472 mL), Product No. 2523, Bar Code 015794025238, and 32 FL. OZ. (1 QT) (944 mL), Product No. 2522, Bar code 015794025221 --- Manufactured…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2215-2014·2014-07-30

    Kraft Recalls Knudsen, Breakstone's, and Other Cottage Cheese Brands

    Kraft Foods is voluntarily recalling multiple cottage cheese brands due to ingredients not stored at proper temperatures.

    Product
    Cottage Doubles - cottage cheese, 2% milkfat, with mango topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2014·2014-07-30

    Exactech Recalls NOVATION Femoral Stems Lacking Plasma Coating

    Exactech is recalling 10 NOVATION Femoral Stems because they lack the specified plasma coating. The devices were distributed worldwide.

    Product
    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2106-2014·2014-07-30

    Terumo CPB Catheter Kit Recalled for Loose Fiber Particulate

    Terumo CVS is recalling 125 CPB Catheter Kits because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2216-2014·2014-07-30

    Kraft Recalls Cottage Cheese Due to Improper Ingredient Storage

    Kraft Foods is voluntarily recalling specific cottage cheese products because ingredients were not stored at proper temperatures, creating a potential safety risk.

    Product
    Cottage cheese, 2% milkfat, with pineapple sold under the Breakstone's brand or Knudsen brand and packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2014·2014-07-30

    Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

    Teleflex Medical is recalling 11,679 Hudson RCI Breathing Circuits because the temperature probe does not properly connect to the temperature port.

    Product
    Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2097-2014·2014-07-30

    Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Malleable Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2014·2014-07-30

    Philips QLAB 10.1 Software Recalled for Incorrect Measurement Defect

    Philips Ultrasound is recalling QLAB 10.1 software because a defect may cause incorrect measurement values under specific conditions.

    Product
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Medical Device
    Distribution
    10 states