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.

13901–13925 of 21617

  • ModerateFDA (Devices)·Z-2843-2016·2016-09-28

    OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates

    OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling.

    Product
    3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2858-2016·2016-09-28

    Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure

    Abbott Medical Optics is recalling 65 units of TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2838-2016·2016-09-28

    Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error

    The Anspach Effort, Inc. is recalling 88 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.

    Product
    G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2840-2016·2016-09-28

    Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error

    The Anspach Effort, Inc. is recalling 69 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.

    Product
    G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2846-2016·2016-09-28

    Carefusion Recalls Pediatric Oxygen Delivery Modules Due to Incorrect Airway Size

    Carefusion 2200 Inc is recalling Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Modules because they contain an 8 cm airway instead of the labeled 5 cm size.

    Product
    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1506-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, 12.5 mg, because they failed impurities and degradation specifications.

    Product
    Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2873-2016·2016-09-28

    Hospira LifeCare PCA Infusion System Recalled for Screw Rotation Error

    Hospira Inc. is recalling 8,794 LifeCare PCA Infusion Systems because a screw rotation error can cause the pump to alarm and stop infusion.

    Product
    LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2854-2016·2016-09-28

    EKOS Intelligent Drug Delivery Catheter Recalled for Potential Epoxy Defect

    EKOS Corporation is recalling 10 Intelligent Drug Delivery Catheters due to potential non-compliant manufacturing tests that may cause epoxy blisters.

    Product
    EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2864-2016·2016-09-28

    Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure

    Abbott Medical Optics is recalling 41 intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2837-2016·2016-09-28

    Anspach Effort Recalls G1 Dissection Tools Due to Release Error

    The Anspach Effort, Inc. is recalling 177 G1 Dissection Tools because they were inadvertently released from hold status and distributed.

    Product
    G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2836-2016·2016-09-28

    SybronEndo Recalls Sealapex Xpress Root Canal Resin Due to Labeling Error

    SybronEndo is recalling 179 units of Sealapex Xpress root canal filling resin because the product was labeled with an incorrect expiration date.

    Product
    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2865-2016·2016-09-28

    Merge Cardio software recall for missing patient information on report pages

    Merge Healthcare is recalling Merge Cardio software version 10.1 because patient information is missing from subsequent report pages.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1517-2016·2016-09-28

    Mucinex Sinus-Max Day Night Recalled for Labeling Errors

    Reckitt Benckiser is recalling Mucinex Sinus-Max Day Night caplets because the outer carton lists incorrect drug strength and quantity.

    Product
    Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2844-2016·2016-09-28

    OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates

    OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling. The devices were distributed nationwide to specific states.

    Product
    3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2863-2016·2016-09-28

    Abbott Recalls 41 Intraocular Lenses Due to Mislabeled Product Risk

    Abbott Medical Optics is recalling 41 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, posing a risk of mislabeling.

    Product
    TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2016·2016-09-21

    Arrow Select Kit Recall Due to Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 Arrow Select Kit units due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2771-2016·2016-09-21

    Arrow International Recalls Select Kit Products Due to Molding Abnormality

    Arrow International is recalling 6,121 units of Select Kit products due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2782-2016·2016-09-21

    Trinity Biotech Captia Measles IgM Test Kit Recalled for QC Failure

    Clark Laboratories is recalling specific lots of the Captia Measles IgM test kit because the product failed quality control stability testing.

    Product
    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2780-2016·2016-09-21

    Mentor Artoura Breast Tissue Expander Recall for Packaging Error

    Mentor Texas, LP. is recalling 48 Artoura Breast Tissue Expanders because CPX4 devices may have been packaged in Artoura boxes.

    Product
    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2781-2016·2016-09-21

    Mentor CPX4 Breast Tissue Expander Recall Due to Packaging Error

    Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders because they may have been packaged in the wrong box.

    Product
    CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2194-2016·2016-09-21

    Good Neighbor Pharmacy Cranberry Tablets Recalled for Labeling Errors

    Reese Pharmaceutical is recalling Good Neighbor Pharmacy Cranberry Tablets because the label omits calcium and lists the wrong serving size.

    Product
    Good Neighbor Pharmacy Cranberry Tablets, Cranberry Supplement 450mg. Urinary Health. Tablets are packed in a labeled carton, 50 tablets per carton. Distributed by Amerisource Bergen 1300 Morris Drive Chesterbrook, PA 19087.
    Category
    Food
    Distribution
    19 states
  • ModerateUSDA FSIS·085-2016·2016-09-21

    Black Forest Ham Products Recalled Due To Possible Rubber Contamination

    502 Boundary Blvd. is recalling Black Forest Ham products due to possible rubber contamination. No adverse reactions have been reported.

    Product
    502 Boundary Blvd. Recalls Black Forest Ham Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2792-2016·2016-09-21

    Stryker Recalls Mislabelled Femoral and Tibial Nails

    Stryker Howmedica Osteonics Corp. is recalling specific femoral and tibial nails that were incorrectly labeled and distributed to California.

    Product
    Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and…
    Category
    Medical Device
    Distribution
    1 state