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.

14751–14775 of 21645

  • ModerateFDA (Devices)·Z-1607-2016·2016-05-11

    Toshiba Celesteion PET/CT Systems Recalled for Detector Performance Degradation

    Toshiba American Medical Systems is recalling three Celesteion PET/CT systems due to potential degradation of detector performance.

    Product
    Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1231-2016·2016-05-11

    Iowa Select Herbs Wormseed Recalled for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Wormseed, www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1151-2016·2016-05-11

    Iowa Select Herbs Recalls Boswellia Serrata for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Boswellia Serrata, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1183-2016·2016-05-11

    Iowa Select Herbs Recalls Gymnema Sylvestre Supplements for Misbranding

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

    Product
    Iowa Select Herbs LLC, Gymnema Sylvestre (Gymnena sylvestre), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1208-2016·2016-05-11

    Iowa Select Herbs Recalls Organic Pomegranate Oil Due to Misbranding

    Iowa Select Herbs LLC is recalling Organic Cold-Pressed Pomegranate Oil because it is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Organic Cold-Pressed Pomegranate Oil, 7.5 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1148-2016·2016-05-11

    Iowa Select Herbs Recalls Black Cohosh Root for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Black Cohosh Root, www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1185-2016·2016-05-11

    Iowa Select Herbs Recalls Hibiscus Flowers for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Hibiscus Flowers under a consent decree because the products are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Hibiscus Flowers (Hibiscus sabdariffa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0835-2016·2016-05-11

    Akorn Recalls PEG-Phen Lubricant Eye Drops Due to Particulate Matter

    Akorn, Inc. is recalling specific batches of PEG-Phen Lubricant Eye Drops because they contain particulate matter. Consumers should stop using the affected products.

    Product
    Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2016·2016-05-11

    Livongo Health Recalls In Touch Blood Glucose Monitoring System Inserts

    Livongo Health is recalling 63,000 units of the In Touch Blood Glucose Monitoring System because the instructional insert omitted specific sensor accuracy limitations.

    Product
    The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1592-2016·2016-05-11

    Siemens ACUSON SC2000 Ultrasound System Recalled for Trackball Control Failure

    Siemens is recalling 87 ACUSON SC2000 ultrasound systems because the trackball may fail to control specific imaging parameters during transesophageal procedures.

    Product
    ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1171-2016·2016-05-11

    Iowa Select Herbs Recalls Echinacea Purpurea for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Echinacea Purpurea, www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz. (d) 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1604-2016·2016-05-11

    Ferno-Washington Recalls Traction Splint Straps Due to Incorrect Packaging Labels

    Ferno-Washington Inc. is recalling 270 traction splint strap kits because the outside packaging labels for adult and pediatric sizes were swapped.

    Product
    Poly-bags containing the strap labeled with "Adult" 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-1135-2016·2016-05-11

    Iowa Select Herbs Recalls Acia Berry Supplement Due to Misbranding

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

    Product
    Iowa Select Herbs LLC, Acia Berry (Euterpe oleracea), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1602-2016·2016-05-11

    Medtronic Midas Rex Dissecting Tools Recalled for Labeling Errors

    Medtronic is recalling 81 Midas Rex Dissecting Tools due to incorrect color coding and attachment references on the labeling.

    Product
    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1309-2016·2016-05-11

    Strong America Recalls Welltop Fried Dace for Leucomalachite Green

    Strong America Limited is recalling Welltop Fried Dace because FDA sampling found leucomalachite green. The product was distributed in New York.

    Product
    Welltop Fried Dace, Net Weight 184g, Product of China, packed for Hui Zhou Welltop Foods Import and Export Co. Ltd. Importer: Guong Aik Sdn. Bhd No. 13 Long Bridge Road, PO Box 1056, 96008, Sibu, Sarawak, East Malaysia, Importer Strong America Ltd, 2-39 54th Ave., Long Island…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1210-2016·2016-05-11

    Iowa Select Herbs Recalls Propolis Resin Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Propolis Resin (Ligustrum lucidum), 2 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1156-2016·2016-05-11

    Iowa Select Herbs Recalls Cat's Claw Supplement Due to Misbranding

    Iowa Select Herbs LLC is recalling Cat's Claw dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Cat's Claw (Uncaria tomentosa), www.iowaselectherbs.com, 7.5 Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1591-2016·2016-05-11

    Biosense Webster Recalls Pentaray Catheters for Labeling Clarification

    Biosense Webster is recalling Pentaray Catheters to clarify contraindication language regarding patients with prosthetic valves in the product labeling.

    Product
    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 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 (Food)·F-1205-2016·2016-05-11

    Iowa Select Herbs Recalls Osha Root for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Osha Root (Ligusticum porteri), 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-1227-2016·2016-05-11

    Iowa Select Herbs Turmeric Recalled for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Tumeric, www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1226-2016·2016-05-11

    Iowa Select Herbs Recalls Suma Root Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Suma Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1157-2016·2016-05-11

    Iowa Select Herbs Recalls Chamomile Flowers for Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Chamomile Flowers (Chamomilla recutita), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1155-2016·2016-05-11

    Iowa Select Herbs Recalls Cascara Root Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Cascara Root (Rhamnus purshiana), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1167-2016·2016-05-11

    Iowa Select Herbs Recalls Damiana Leaf Due to Misbranding and Adulteration

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

    Product
    Iowa Select Herbs LLC, Damiana Leaf (Turnera diffusa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1207-2016·2016-05-11

    Iowa Select Herbs Recalls Organic Papaya Leaf Capsules for Misbranding

    Iowa Select Herbs LLC is recalling Organic Papaya Leaf capsules because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Organic Papaya Leaf (paw paw/papain), 500 mg, 60 Capsules, www.iowaselectherbs.com, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide