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.

10076–10100 of 21617

  • ModerateFDA (Devices)·Z-2923-2018·2018-09-05

    Tecan Recalls Cortisol Saliva Luminescence Immunoassay Kits for Inaccurate Results

    Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.

    Product
    Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. Th
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2914-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2943-2018·2018-09-05

    Bard Midstream Urine Collector Recalled for Iodine Prep Pad Deficiency

    Bard Medical Division is recalling 131,950 urine collection kits because the included iodine prep pads failed to meet required assay levels for their expiration dating.

    Product
    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateNHTSA·18V591000·2018-09-05

    Mitsubishi Outlander Recall for Incorrect Rear Wheel Rim Size Label

    Mitsubishi is recalling 2018-2019 Outlander vehicles with 18-inch alloy wheels because the certification label lists an incorrect rear wheel rim size.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1902-2018·2018-09-05

    Ararat Imambayeldy Recalled Due to pH Levels Above Scheduled Process

    Artashes LLC is recalling Ararat Imambayeldy because FDA inspections found pH levels above the scheduled process.

    Product
    Ararat Imambayeldy; 18.3 oz. glass jar; Ingredient: Eggplant, tomato paste, onions, vegetable oil, garlic, green salt Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2903-2018·2018-09-05

    Stryker Quikflap Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling Quikflap burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2905-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise

    Stryker Leibinger is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2904-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2952-2018·2018-09-05

    Luminex Recalls Verigene Enteric Pathogens Test Cartridges Due to False Positives

    Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test Cartridges because they may produce elevated false positive results for Yersinia enterocolitica.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointesti
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2907-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1169-2018·2018-09-05

    Pfizer Recalls Children's Advil Suspension Due to Dosage Cup Labeling Error

    Pfizer is recalling 17,136 bottles of Children's Advil Suspension because the included dosage cup is marked in teaspoons while the label instructions use milliliters.

    Product
    CHILDRENS ADVIL — CHILDRENS ADVIL (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2945-2018·2018-09-05

    Ceterix Disposable Knot Pusher Recalled for High Cut Force

    Ceterix Orthopedics is recalling 96 units of the Disposable Knot Pusher / Suture Cutter because nonconforming blades may require higher than specified cut force.

    Product
    Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2909-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2949-2018·2018-09-05

    DePuy P.F.C. SIGMA Revision Knee Distal Augment Recall

    DePuy Orthopaedics is recalling one P.F.C. SIGMA Revision Knee System Distal Augment because it may be missing the screw/collet assembly. The device was not distributed in the United States.

    Product
    P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2900-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2913-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall for Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2953-2018·2018-09-05

    Sysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts

    Sysmex America is recalling Fluorocell PLT reagent because it may cause falsely low platelet and immature platelet fraction results.

    Product
    Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2902-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2899-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Packs Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy an
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2957-2018·2018-09-05

    Baxter Recalls FLOSEAL Special Applicator Tips Due to Plastic Formulation Error

    Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.

    Product
    FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1904-2018·2018-09-05

    Ararat Grilled Eggplant and Peppers Recalled for pH Levels

    Artashes LLC is recalling Ararat Grilled Eggplant and Peppers because FDA inspection found pH levels above the scheduled process.

    Product
    Ararat Grilled Eggplant and Peppers 23 oz. glass jar; Ingredients: Eggplants, tomatoes, green pepper, salt. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2901-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2948-2018·2018-09-05

    Medline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging

    Medline Industries is recalling 90,870 units of 0.9% Sodium Chloride Injection due to incorrect overwrap packaging. The product is intended for flushing IV catheters and tubing.

    Product
    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2944-2018·2018-09-05

    Roche cobas p 612 Pre-Analytical System Recalled for Contamination Risk

    Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.

    Product
    Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for u
    Category
    Medical Device
    Distribution
    5 states