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.

16551–16575 of 21645

  • ModerateFDA (Food)·F-1922-2015·2015-04-15

    Nutri-Dyn Recalls 5-HTP Extra Strength Capsules Due to Mislabeling

    Nutri-Dyn Midwest, Inc. is recalling 5-HTP Extra Strength dietary supplements because bottles were mistakenly labeled during CoQ-10 production.

    Product
    Nutri-Dyn, 5-HTP Extra Strength, Pharmaceutical Grade from Switzerland, Dietary Supplement 60 capsules in plastic bottle, 5-Hydroxytryptophan (5-HTP) 200 mg., Other Ingredients: Rice flour, magnesium stearate, and silica, UPC # 6 96859 02947 9, Sku # R200E.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1379-2015·2015-04-15

    TEM Systems Recalls ROTROL P Control Vials Due to Partial Filling

    TEM Systems Inc is recalling specific lots of ROTROL P Control vials because some were found to be partially filled.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Arm Drapes due to a cloudy appearance and potential to tear or transfer waxy substance to patients.

    Product
    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1387-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Instrument Arm Drapes Due to Defects

    Intuitive Surgical is recalling da Vinci S/Si Instrument Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1383-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Patient-Cart Monitor Drapes

    Intuitive Surgical is recalling da Vinci S Patient-Cart Monitor Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0484-2015·2015-04-15

    RemedyRepack Recalls Ketorolac Tromethamine Injection Vials Due to Crystallization

    RemedyRepack Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The affected vials were distributed in Pennsylvania and Oklahoma.

    Product
    KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1388-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Camera Arm Drapes for Defects

    Intuitive Surgical is recalling da Vinci S/Si Camera Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1399-2015·2015-04-15

    Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error

    Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.

    Product
    ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0436-2015·2015-04-15

    Heritage Pharmaceuticals Recalls Gliptizide and Metformin Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling specific lots of Gliptizide and Metformin HCL tablets because they failed impurity specifications. The affected bottles were distributed nationwide.

    Product
    GLIPIZIDE AND METFORMIN HCL — GLIPIZIDE AND METFORMIN HCL (GLIPIZIDE AND METFORMIN HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1332-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1674-2015·2015-04-08

    Health One Pharmaceuticals Recalls Salvia Dietary Supplements

    Health One Pharmaceuticals is recalling Salvia dietary supplements due to significant violations of current good manufacturing practices (cGMP) regulations.

    Product
    Salvia, 100 Vegetarian Capsules, 500mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1748-2015·2015-04-08

    Health One Pharmaceuticals Recalls Prostalyn Dietary Supplements

    Health One Pharmaceuticals is recalling Prostalyn dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Prostalyn, 60 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1643-2015·2015-04-08

    Health One Pharmaceuticals Recalls Herbal Mix Dietary Supplements

    Health One Pharmaceuticals is recalling Herbal Mix dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Herbal Mix
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1637-2015·2015-04-08

    Health One Recalls Menopause Dietary Supplements for cGMP Violations

    Health One Pharmaceuticals is recalling Best Women's Formula for Menopause capsules due to significant violations of cGMP regulations for dietary supplements.

    Product
    Best Women's Formula for Menopause, 90 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1677-2015·2015-04-08

    Health One Pharmaceuticals Recalls Optium Joint Rx Dietary Supplement

    Health One Pharmaceuticals is recalling Optium Joint Rx dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Optium Joint Rx, 90 Tablets
    Category
    Food
    Distribution
    Distributed nationwide