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.

14676–14700 of 21645

  • ModerateFDA (Devices)·Z-1590-2016·2016-05-11

    Biosense Webster Recalls Pentaray Catheters for Labeling Clarification

    Biosense Webster is recalling Pentaray NAV High-Density Mapping Catheters to clarify contraindication language regarding patients with prosthetic valves.

    Product
    Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2016·2016-05-11

    Alcon Recalls INFINITI Ultrasound Packs Due to Tubing Leakage

    Alcon Research is recalling INFINITI Ultrasound Packs because the irrigation line tubing may leak near the white luer.

    Product
    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1593-2016·2016-05-11

    Carestream Image Suite V3 Recalled for Incorrect Image Annotation

    Carestream Health is recalling Image Suite V3 units due to a software error that displays incorrect left/right image annotations.

    Product
    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1594-2016·2016-05-11

    Carestream Image Suite V4 Recalled for Incorrect Image Annotation Display

    Carestream Health is recalling Image Suite V4 systems because a complaint reported that image annotations displayed 'L (Left)' instead of 'R (Right)'.

    Product
    CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1178-2016·2016-05-11

    Iowa Select Herbs Recalls Ginkgo Biloba for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Ginkgo Leave (Ginkgo biloba), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1163-2016·2016-05-11

    Iowa Select Herbs Recalls Cold Be Gone for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Cold Be Gone, www.iowaselectherbs.com, (a) 1/2 fl. Oz., (b) 15 ml, (c) 1 fl. Oz., (d) 30 ml (e) unknown size, Cedar Rapids, IA 52402
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1158-2016·2016-05-11

    Iowa Select Herbs Recalls Chaparral Leaf Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Chaparral Leaf (Larrea tridentata), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1212-2016·2016-05-11

    Iowa Select Herbs Recalls Pygeum Bark Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Pygeum Bark, www.iowaselectherbs.com, (a) 4 fl Oz. (b) unknown size, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1201-2016·2016-05-11

    Iowa Select Herbs Recalls Olive Leaf Supplements Due to Misbranding

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

    Product
    Iowa Select Herbs LLC, Olive Leaf (Olea europa), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 1 gallon (d) Unknown size. Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1152-2016·2016-05-11

    Iowa Select Herbs Recalls Broad Beans for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Broad Beans because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Broad Beans, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1153-2016·2016-05-11

    Iowa Select Herbs Recalls Buchu Leaf for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Buchu Leaf, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1235-2016·2016-05-11

    Iowa Select Herbs Recalls Dandelion Root for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Alcohol-Free, Dandelion Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1603-2016·2016-05-11

    Ferno-Washington Recalls Pediatric Traction Splint Straps Due to Labeling Error

    Ferno-Washington is recalling 153 pediatric traction splint strap kits because they were shipped in adult-labeled packaging. This labeling error could lead to the use of the wrong size equipment for patients.

    Product
    Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-1194-2016·2016-05-11

    Iowa Select Herbs Marshmallow Root Recalled for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Marshmallow Root (Althaea officinalis), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1140-2016·2016-05-11

    Iowa Select Herbs Recalls Artichoke Leaf Extract for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 10 bottles of Artichoke Leaf extract because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Artichoke Leaf (Cynara Scolymus), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1160-2016·2016-05-11

    Iowa Select Herbs Recalls Alcohol-Free Cilantro Leaf for Misbranding

    Iowa Select Herbs LLC is recalling alcohol-free cilantro leaf products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, Cilantro Leaf, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0837-2016·2016-05-11

    Bryant Ranch Recalls Venlafaxine Tablets Due to Labeling Error

    Bryant Ranch Prepack Inc. is recalling venlafaxine hydrochloride extended-release tablets that were incorrectly labeled as immediate-release.

    Product
    VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1149-2016·2016-05-11

    Iowa Select Herbs Recalls Black Currant Supplement for Misbranding

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

    Product
    Iowa Select Herbs LLC, Black Currant (Ribes nigrum), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1141-2016·2016-05-11

    Iowa Select Herbs Recalls Ashwaganda Root Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Ashwaganda Root (Withania somnifera), www.iowaselectherbs.com, (a) 1 fl. Oz. and (b) 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1215-2016·2016-05-11

    Iowa Select Herbs Recalls Reishi Mushroom Product Due to Misbranding

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

    Product
    Iowa Select Herbs LLC, Reishi Mushroom (Ganoderma Lucidum), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1176-2016·2016-05-11

    Iowa Select Herbs Recalls Garcinia Fruit Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Garcinia Fruit (Garcinia cambogia), www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1181-2016·2016-05-11

    Iowa Select Herbs Recalls Soursop Leaf Product for Misbranding

    Iowa Select Herbs LLC is recalling Graviola Leaf "Soursop" products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Graviola Leaf "Soursop" (Annona muricata), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1217-2016·2016-05-11

    Iowa Select Herbs Recalls Rhubarb Root Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Rhubarb Root (Rhizoma rhei), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1191-2016·2016-05-11

    Iowa Select Herbs Licorice Root Recalled for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling specific lots of Licorice Root because the products are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Licorice Root (Glycyrrhiza glabra), www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1179-2016·2016-05-11

    Iowa Select Herbs Recalls Goldenseal Root for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Goldenseal Root (Hydrastis canadensis), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 32 fl. Oz. (c) 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide