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.

11926–11950 of 21617

  • ModerateFDA (Devices)·Z-3076-2017·2017-09-06

    BioMérieux Recalls VITEK 2 Compact 30 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 30 software and reagent cards because a software update prevents test cards from finalizing results, potentially disrupting laboratory processing.

    Product
    VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3077-2017·2017-09-06

    Edwards Lifesciences Recalls Fogarty Adherent Clot Catheters Due to Balloon Size Error

    Edwards Lifesciences is recalling specific Fogarty Adherent Clot Catheters because the balloon diameter measures 6mm instead of the intended 10mm.

    Product
    Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0008-2018·2017-09-06

    Optovue iVue Recall for Missing 510(k) on Vault Mapping Software

    Optovue is recalling 326 iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.

    Product
    iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3092-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0009-2018·2017-09-06

    Optovue iFusion and iVue Recalled for Missing 510(k) Approval

    Optovue is recalling 326 iFusion and iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.

    Product
    iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3078-2017·2017-09-06

    Certified Safety Mfg Recalls Sterile Burn Sheets for Shredding Risk

    Certified Safety Mfg Inc is recalling sterile burn sheets included in first aid kits because they may shred, potentially failing to protect patients from infection.

    Product
    Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3468-2017·2017-09-06

    KIND Breakfast Dark Chocolate Cocoa Bars Recalled for Mislabeling

    KIND, LLC is recalling 4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars because the outer boxes may be mislabeled and contain KIND Breakfast PROTEIN Dark Chocolate Cocoa Bars.

    Product
    4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars 1.76 oz (50g) Outer Box: UPC: 60265220102-8
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3097-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3101-2017·2017-09-06

    Beckman Coulter UniCel DxH Slidemaker Stainer Recall for Fitting Seal Defect

    Beckman Coulter is recalling 310 UniCel DxH Slidemaker Stainer units because a fitting may not completely seal after installation.

    Product
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3410-2017·2017-08-30

    Zydot Detox Drink Recalled for Undeclared Yellow #5 Dye

    Zydot Unlimited is recalling 9,101 bottles of Zydot Ultimate Blend Detox Drink because the product contains undeclared Yellow #5 dye.

    Product
    Zydot Ultimate Blend Detox Drink Natural Tropical Ice Flavor 32 fl. oz. (946 ml) and 16 fl. oz. (473 ml) packaged in clear plastic bottles
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1113-2017·2017-08-30

    C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

    C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 60 mg, due to a label mixup that may result in mislabeling.

    Product
    Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1114-2017·2017-08-30

    Phenobarbital Tablets Recalled for Potential Labeling Errors

    C. O. Truxton is recalling Phenobarbital Tablets USP, 100 mg, due to a label mixup that may result in mislabeled products.

    Product
    Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3062-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans Filtron 500 Due to Seal Integrity

    Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 500 because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3465-2017·2017-08-30

    The Best Bar Ever Recalls Peanut Butter Crunch Bars Due to Labeling Error

    The Best Bar Ever Inc. is voluntarily recalling Peanut Butter Crunch bars because the individual wrappers incorrectly display a gluten-free logo, although the product ingredients and allergen statements are accurate.

    Product
    The Best Bar Ever, Peanut Butter Crunch, 1.41 oz., 40 gm.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3055-2017·2017-08-30

    Medtronic ENT Instrument Set Recalled for Verification Failure

    Medtronic is recalling 13 reusable ENT instrument sets because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.

    Product
    Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3046-2017·2017-08-30

    Cardinal Health Recalls Mispackaged Robotic Surgical Drapes

    Cardinal Health 200, LLC is recalling 200 units of Robotic Drape with Leggings that were incorrectly packaged as LAVH drapes.

    Product
    Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3068-2017·2017-08-30

    Pentax Ultrasound Video Gastroscope Recall Due to Instruction Error

    Pentax of America Inc is recalling 116 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.

    Product
    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1115-2017·2017-08-30

    C. O. Truxton Recalls Mislabeled Amitriptyline HCL Tablets

    C. O. Truxton is recalling specific lots of Amitriptyline HCL 50 mg tablets due to potential label mixups. The recall is nationwide.

    Product
    Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3053-2017·2017-08-30

    Medtronic Curved Suction 90 Recalled for Verification Failure

    Medtronic is recalling 75 Curved Suction 90 ENT instruments because they fail required pre-use verification checks.

    Product
    Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1118-2017·2017-08-30

    PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    PD-Rx Pharmaceuticals is recalling 3,440 bottles of Phentermine Hydrochloride capsules because stability tests showed out-of-specification unknown impurities.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3067-2017·2017-08-30

    Pentax Ultrasound Video Gastroscope Recalled for Incorrect Disinfection Instructions

    Pentax of America Inc. is recalling 118 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.

    Product
    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2812-2017·2017-08-30

    Ito En Recalls Royal Mills Iced Cappuccino Due to Quality Complaints

    Ito En (USA) Inc. is recalling 38 cases of Royal Mills Iced Cappuccino after receiving complaints of sour taste, off odor, and sediment.

    Product
    Royal Mills, Iced Cappuccino, Premium Coffee. 11.0 FL. OZ. (325 ml) 2-piece aluminum can; Made in Hawaii. UPC: 0 73366 12755
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1116-2017·2017-08-30

    C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

    C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 15 mg, due to a label mixup that may result in mislabeled products.

    Product
    Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3365-2017·2017-08-23

    Kettle Brand Potato Chips Recalled for Incorrect Carbohydrate Labeling

    Kettle Foods is recalling Kettle Brand Krinkle Cut Potato Chips Spicy Queso because the carbohydrate content on the label is incorrect.

    Product
    Kettle Brand Krinkle Cut Potato Chips Spicy Queso, 8.5 oz., Distributed by: Kettle Foods, Inc., Salem, OR 97301, UPC: 84114 90042
    Category
    Food
    Distribution
    11 states