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.

1651–1675 of 2769

  • LowFDA (Devices)·Z-1642-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1629-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 707 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1168-2016·2016-05-11

    Iowa Select Herbs Recalls Dandelion Leaf for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 26 bottles of Dandelion Leaf due to misbranding, unapproved new drug status, and adulteration under a consent decree.

    Product
    Iowa Select Herbs LLC, Dandelion Leaf (Taraxacum officinale), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1188-2016·2016-05-11

    Iowa Select Herbs Recalls Juniper Berry Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Juniper Berry products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Juniper Berry (Juniperus communis), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1219-2016·2016-05-11

    Iowa Select Herbs Recalls Sangre De Grado Due to Misbranding

    Iowa Select Herbs LLC is recalling Sangre De Grado (Rhizoma rhei) because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Sangre De Grado (Rhizoma rhei), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1224-2016·2016-05-11

    Iowa Select Herbs Recalls Solomon Seal Supplements for Misbranding

    Iowa Select Herbs LLC is recalling Solomon Seal dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Solomon Seal, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0839-2016·2016-05-11

    A-S Medication Solutions Recalls Acetaminophen and Codeine Tablets Due to Labeling Error

    A-S Medication Solutions LLC is recalling 2,730 bottles of Acetaminophen & Codeine Phosphate Tablets because the count on the label was incorrect.

    Product
    Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0836-2016·2016-05-11

    Hospira Recalls Quelicin Injection Due to Faded or Missing Label Dates

    Hospira Inc. is recalling 103,600 vials of Quelicin (Succinylcholine Chloride) Injection because the lot number or expiration date may be faded or missing from the primary label.

    Product
    QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1145-2016·2016-05-11

    Iowa Select Herbs Beet Root Recalled for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Beet Root products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Beet Root (Beta vulgaris), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1193-2016·2016-05-11

    Iowa Select Herbs Recalls Magnolia Bark for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 1-gallon bottles of Alcohol-Free Magnolia Bark because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, Magnolia Bark www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1211-2016·2016-05-11

    Iowa Select Herbs Recalls Psoralea Seed for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Psoralea Seed under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Psoralea Seed (Psoralea corylifolia), 1 gallon, www.iowaselectherbs.com, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1150-2016·2016-05-11

    Iowa Select Herbs Recalls Blood Root Supplement Due to Misbranding

    Iowa Select Herbs LLC is recalling Blood Root dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Blood Root (Sanguinaria canadenix), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1229-2016·2016-05-11

    Iowa Select Herbs Recalls White Peony Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling White Peony Root products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, White Peony Root (Paeonia lactiflora), www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 4 fl. Oz., (c) 16 fl. Oz., (d) 32 fl. Oz., (e) 40 fl. Oz., (f) unknown size, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1195-2016·2016-05-11

    Iowa Select Herbs Recalls Milk Thistle Supplement for Misbranding

    Iowa Select Herbs LLC is recalling 12 bottles of Alcohol Free Milk Thistle because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Alcohol Free, Milk Thistle, www.iowaselectherbs.com, 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1225-2016·2016-05-11

    Iowa Select Herbs Recalls St John's Wart Due to Misbranding

    Iowa Select Herbs LLC is recalling St John's Wart products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, St John's Wart, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1198-2016·2016-05-11

    Iowa Select Herbs Recalls Muira Puama Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Muira Puama products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Muira Puama (Ptychopetalum ovata), www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 2 fl. Oz. (c) 4 fl. Oz. (d) 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1282-2016·2016-05-04

    Bliss Bros Dairy Recalls Newport Creamery Butter Crunch Ice Cream

    Bliss Bros Dairy, Inc. is recalling Newport Creamery Butter Crunch Ice Cream because the product failed to meet air space specifications.

    Product
    Newport Creamery Butter Crunch Ice Cream, 3Gal Product Code: 35108
    Category
    Food
    Distribution
    7 states
  • LowFDA (Devices)·Z-1581-2016·2016-05-04

    LED Technologies Recalls reVive Light Therapy Devices Due to Power Supply Error

    LED Technologies, LLC is recalling 32 units of the reVive Light Therapy Pain Relief Device because an incorrect power supply was included, rendering the devices inoperable.

    Product
    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pai
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-1273-2016·2016-05-04

    Bliss Bros Dairy Recalls Emack & Bolios Ice Cream for Air Space Defect

    Bliss Bros Dairy is recalling Emack & Bolios Serious Choc Addiction Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Serious Choc Addiction Ice Cream 3gal Product Code: 36271
    Category
    Food
    Distribution
    7 states