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.

26–50 of 21707

  • ModerateFDA (Devices)·Z-0149-2027·2026-10-21

    BioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination

    BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panel Plus kits due to potential contamination that could cause false positive results.

    Product
    Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0159-2027·2026-10-21

    Microgenics Recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control

    Microgenics Corporation is recalling MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control products due to vial-to-vial variability that may delay patient PTH results.

    Product
    MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0148-2027·2026-10-21

    BioFire FilmArray Pneumonia Panel Recalled for Potential Contamination

    BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panels due to potential contamination that could result in false positive test results.

    Product
    Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0041-2027·2026-10-21

    Houston Rx LLC Recalls Sermorelin Vials Due to Process Control Issues

    Houston Rx LLC is recalling 7 vials of Sermorelin injectable solution due to a lack of process control. The product was distributed nationwide.

    Product
    Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0189-2027·2026-10-21

    Medline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy

    Medline is recalling 30 Foot Ankle convenience kits due to a discrepancy in the shelf-life of a component.

    Product
    Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2027·2026-10-21

    BioFire Joint Infection Panel Recalled for Potential Contamination

    BioFire Diagnostics is recalling specific lots of the Joint Infection Panel due to potential contamination that could cause false positive test results.

    Product
    Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0142-2027·2026-10-21

    Neuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables

    Neuronetics is recalling 179 NeuroStar Advanced Therapy Systems because the cables in the HP Coil Assembly do not meet product specifications.

    Product
    NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0188-2027·2026-10-21

    Healthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance

    Healthmark Industries is recalling 12.8 million vinyl instrument guards because their labeling does not comply with FDA regulations and steam sterilization instructions have been updated.

    Product
    Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2027·2026-10-21

    Howmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk

    Howmedica Osteonics Corp. is recalling 359 Triathlon Hinge Femoral Prep Trays because reprocessing instructions may leave residual moisture after sterilization.

    Product
    Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0178-2027·2026-10-21

    Medline surgical convenience kits recalled for non-conforming cannula components

    Medline is recalling 165 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0185-2027·2026-10-21

    Medline Recalls CONMED AirSeal Access Port Kits Due to Overpressure Alerts

    Medline Industries is recalling 3,551 CONMED AirSeal Access Port kits due to potential overpressure alerts and system venting that may delay or end procedures.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0164-2027·2026-10-21

    Howmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk

    Howmedica Osteonics Corp. is recalling 605 Triathlon Universal Baseplate Finishing Trays because reprocessing instructions may leave residual moisture after sterilization.

    Product
    TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0157-2027·2026-10-21

    In2bones Recalls Partially Threaded Bone Screws Due to Labeling Error

    In2bones USA, LLC is recalling 29 bone screws labeled as fully threaded but actually partially threaded due to a labeling error.

    Product
    REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2027·2026-10-21

    Medline recalls CONMED AirSeal Access Port kits due to pressure alerts

    Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports because they may produce erroneous overpressure alerts and system venting.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2027·2026-10-21

    Radiometer ABL90 FLEX Analyzers Recalled for Inaccurate Results

    Radiometer Medical ApS is recalling ABL90 FLEX and ABL90 FLEX PLUS analyzers due to a risk of potentially inaccurate results requiring updated instructions for use.

    Product
    The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0187-2027·2026-10-21

    Merit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues

    Merit Medical Systems is recalling Scout MD Delivery Systems because the implantable clip may fail to deploy, preventing the reflector from functioning as intended.

    Product
    Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0101-2027·2026-10-14

    Avid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination

    Avid Medical, Inc. is recalling 30 DAVINCI LAP/GYN kits (Model WRNM037-16) because they may be contaminated with a lubricant used during manufacturing.

    Product
    DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0090-2027·2026-10-14

    Onkos My3D Personalized Pelvic Implant Recalled for Distribution Error

    Onkos Surgical is recalling My3D Personalized Pelvic Implants that were inadvertently mixed up and distributed to incorrect customers.

    Product
    Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0095-2027·2026-10-14

    AVID Medical Recalls 33 Endovascular Packs Due to Lubricant Contamination

    AVID Medical, Inc. is recalling 33 Endovascular Packs (Model VAPX014-04) because they may be contaminated with a lubricant used during manufacturing.

    Product
    ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0012-2027·2026-10-14

    BioSpectra Recalls Tris/Tromethamine API Due to Failed Stability Specifications

    BioSpectra, Inc. is recalling 200 kg of Tris/Tromethamine API distributed in California because the product failed stability specifications.

    Product
    Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0103-2027·2026-10-14

    AVID Medical Recalls Urology Kits for Potential Lubricant Contamination

    AVID Medical, Inc. is recalling 20 Urology Major kits (Model WRNM058-10) because they may be contaminated with a lubricant used during manufacturing.

    Product
    UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0082-2027·2026-10-14

    DRG Sperm Ab ELISA Recalled for Potential False Negative Results

    DRG International is recalling Sperm Ab ELISA kits due to a potential for false negative patient results. The recall covers 211 units distributed in the US and several international countries.

    Product
    Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0013-2027·2026-10-14

    Preferred Pharmaceuticals Recalls Lidocaine Ointment Due to Content Uniformity Failures

    Preferred Pharmaceuticals is recalling Lidocaine Ointment USP, 5% due to failed content uniformity specifications. The product is distributed nationwide.

    Product
    Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0007-2027·2026-10-14

    Mezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination

    G L Mezzetta Inc is recalling 32 fl oz jars of Golden Greek Peperoncini Medium Heat due to potential contamination with mice.

    Product
    Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G.L. MEZZETTA, INC., AMERICAN CANYON, NAPA VALLEY, CA 94503 PRODUCT OF GREECE UPC: 073214003280
    Category
    Food
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0102-2027·2026-10-14

    AVID Medical Recalls Heart Prep Trays for Lubricant Contamination

    AVID Medical, Inc. is recalling 96 Heart Prep Trays (Model MECV97W) because they may be contaminated with a lubricant used during manufacturing.

    Product
    HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
    Category
    Medical Device
    Distribution
    Distributed nationwide