The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

2526–2550 of 2769

  • LowFDA (Food)·F-1271-2013·2013-04-03

    Ultradent Recalls Opalescence Treswhite Supreme Peach Patient Kits

    Ultradent Products, Inc. is recalling 104 units of Opalescence Treswhite Supreme Peach Patient Kits due to incorrect shelf-life labeling.

    Product
    Opalescence Treswhite Supreme Peach Patient Kit
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Food)·F-1265-2013·2013-04-03

    Kettle Foods Recalls Trail Mix Due to Sulfur Dioxide

    Kettle Foods is recalling Natural Chocolate Lovers Trail Mix because it was made with dried pineapple containing sulfur dioxide instead of untreated pineapple.

    Product
    Item #1815, Kettle brand Natural Chocolate Lovers Trail Mix UPC 8411401910 Label reads in part "8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs. ***"
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1010-2013·2013-04-03

    Cooper Surgical Gellhorn Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not accurately reflect the size of the product inside.

    Product
    Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1001-2013·2013-04-03

    CareFusion Recalls Preoperative Skin Prep Products Due to Sterility Labeling Error

    CareFusion is recalling Sepp Compound Benzoin Tincture products because labeling incorrectly implies the antiseptic solution is sterile, when only the applicator is sterile.

    Product
    Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1009-2013·2013-04-03

    Cooper Surgical Gellhorn Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not reflect the actual size of the device inside.

    Product
    Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1004-2013·2013-04-03

    Cooper Surgical Incontinence Ring Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 80 units of Incontinence Ring Flexible Pessaries because the outer packaging may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1008-2013·2013-04-03

    Cooper Surgical Incontinence Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 31 units of Incontinence Dish Folding Pessaries because the outer packaging may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1006-2013·2013-04-03

    Cooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 45 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1012-2013·2013-04-03

    Cooper Surgical Cube Pessary Recalled Due to Mislabeled Outer Packaging

    Cooper Surgical is recalling 20 units of Cube Pessaries because the outer packaging may not reflect the actual product size.

    Product
    Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1266-2013·2013-04-03

    Kettle Brand Honey Roast Nuts and Fruit Trail Mix Recalled for Sulfur Dioxide

    Kettle Foods is recalling Honey Roast Nuts and Fruit Trail Mix because it was made with dried pineapple containing sulfur dioxide instead of untreated pineapple.

    Product
    Item #1900 Kettle Brand Honey Roast Nuts and Fruit Trail Mix UPC 8411401900 Label reads in part "8411401900 Honey Roast Nuts & Fruit Mix Net Weight 24 Lbs. ***"
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1011-2013·2013-04-03

    Cooper Surgical Cube Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 70 units of Cube Pessaries because the outer packaging may not reflect the actual size of the product inside.

    Product
    Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-217-2013·2013-04-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,736 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at the 12-month stability timepoint.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-216-2013·2013-04-03

    L. Perrigo Recalls Subpotent PE Daytime Cold/Flu LiqGel Blister Packs

    L. Perrigo is recalling 60,048 blister packs of PE Daytime Cold/Flu LiqGel because the active ingredient Phenylephrine HCl was subpotent at the 12-month time point.

    Product
    PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-1005-2013·2013-04-03

    Cooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 18 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0988-2013·2013-04-03

    Siemens Dimension Vista Alkaline Phosphatase Calibrator Recalled for Accuracy Shift

    Siemens Healthcare Diagnostics is recalling 1,985 cartons of Dimension Vista Alkaline Phosphatase Calibrators due to correlation slope bias and accuracy shift.

    Product
    Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-215-2013·2013-04-03

    Hospira Recalls Lactated Ringer's Injection Due to CGMP Deviations

    Hospira is recalling 1,296 units of Lactated Ringer's Injection, USP, 1000 mL, because the product was shipped without approval for release.

    Product
    Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-219-2013·2013-04-03

    Pfizer Recalls TORISEL Kits Due to Sterility and Endotoxin Concerns

    Pfizer is recalling 10,920 TORISEL (temsirolimus) kits nationwide due to a lack of assurance of sterility and potential low-level endotoxins in the diluent vials.

    Product
    TORISEL — TORISEL (TEMSIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0966-2013·2013-03-27

    Volk Optical Recalls 20 Diopter Binocular Indirect Ophthalmoscope Lenses

    Volk Optical Inc is recalling 40 units of 20 Diopter Binocular Indirect Ophthalmoscope lenses due to mixed-up lot number engravings on the devices and packaging.

    Product
    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-0974-2013·2013-03-27

    Intio ClearStart-SVM User Manual Recalled for Editing Mistake

    Intio Inc. is recalling seven copies of the ClearStart-SVM User Manual due to an editing mistake that could be interpreted as promoting an unapproved use.

    Product
    INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-201-2013·2013-03-27

    West-ward Recalls Carisoprodol Tablets for Missing C-IV Labeling

    West-ward Pharmaceutical Corp. is recalling 1,763 bottles of Carisoprodol Tablets, 350 mg, because they lack the required C-IV imprint on the label.

    Product
    Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1224-2013·2013-03-27

    MET-Rx Extreme NOS Pumped Double Berry Recalled for Commercial Spoilage

    NBTY Inc. is recalling 5,412 bottles of MET-Rx Extreme NOS Pumped Double Berry dietary supplement because the product's color, odor, and taste have changed, failing quality standards.

    Product
    MET-Rx EXTREME NOS PUMPED DOUBLE BERRY Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 35909 0, Label Revision 01C, Item Number 35909 (Bottle) Item Number 35910 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Ra
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0970-2013·2013-03-27

    Agfa X-Ray Image Plate Recall Due to Incorrect Barcode Labeling

    Agfa Corp. is recalling 17 X-ray image plates shipped with incorrect size barcodes, affecting facilities in 10 US states.

    Product
    CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the ima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1223-2013·2013-03-27

    NBTY Recalls MET-Rx Extreme NOS Pumped Watermelon Dietary Supplement

    NBTY Inc. is recalling 28,068 bottles of MET-Rx Extreme NOS Pumped Watermelon dietary supplement due to commercial spoilage affecting the product's color, odor, and taste.

    Product
    MET-Rx EXTREME NOS PUMPED WATERMELON Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 27603 8, Label Revision 02C, Item Number 27603 (Bottle) Item Number 27604 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Rato
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-211-2013·2013-03-27

    Novartis Recalls 4 Way Saline Moisturizing Mist Due to Labeling Errors

    Novartis Consumer Health is recalling 4 Way Saline Moisturizing Mist bottles because lot numbers or expiration dates may be illegible or missing.

    Product
    4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1225-2013·2013-03-27

    MET-Rx Extreme NOS Pumped Nitro-Punch Recalled for Commercial Spoilage

    NBTY Inc. is recalling 1,176 bottles of MET-Rx Extreme NOS Pumped Nitro-Punch dietary supplement because the product's color, odor, and taste have changed, failing quality standards.

    Product
    MET-Rx EXTREME NOS PUMPED NITRO-PUNCH Naturally Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC Code 7 49826 00512 6, Label Revision 05D, Item Number 48515 --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487
    Category
    Food
    Distribution
    Distributed nationwide