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.

9651–9675 of 21595

  • ModerateFDA (Food)·F-0667-2019·2018-11-28

    Diamond Crystal Barbecue Sauce Recalled for Missing Ingredient Labels

    Diamond Crystal Brands is recalling House Blend Barbecue Sauce because the labels are missing required ingredient information, including soybean oil.

    Product
    HOUSE BLEND Barbecue SAUCE INGREDIENTS: ***Contains 2% or less of Soybean Oil***Onion Powder***Calcium Disodium EDTA***DIAMOND CRYSTAL BRANDS, INC. SAVANNAH, GA 31405
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0388-2019·2018-11-28

    GE Healthcare Recalls DeltaVision OMX SR Imaging Systems Due to Interlock Defect

    GE Healthcare Biosciences is recalling 39 DeltaVision OMX SR Imaging Systems because the safety interlocks are not wired to be single-fault tolerant.

    Product
    DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflectio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0487-2019·2018-11-28

    FDA Mandates Recall of PremierPro Aluminum Adjustable Walkers

    SVS LLC is recalling 256 PremierPro Aluminum Adjustable Walkers due to an FDA order for stock recovery and return of imported items.

    Product
    PremierPro Aluminum Adjustable Walker
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0283-2019·2018-11-28

    Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate tablets because they failed dissolution testing during stability checks.

    Product
    CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0633-2019·2018-11-28

    Mast Store Provisioners Fried Peanuts Recalled for Incorrect Allergen Labeling

    Lehi Valley Trading Co. is recalling 96 bags of Mast Store Provisioners Shell 'N All Fried Peanuts because the ingredient list and allergen information are incorrect.

    Product
    Mast Store Provisioners, Shell 'N All Fried Peanuts, Net Wt. 8 OZ. clear plastic bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0495-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling 8 units of Vanguard Knee System femoral components because outer carton labels do not match inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0273-2019·2018-11-28

    Nitrofurantoin Capsules Recalled for Potential Cross-Contamination with Unrelated Ingredients

    American Health Packaging is recalling specific lots of Nitrofurantoin Capsules due to potential cross-contamination with unrelated active ingredients.

    Product
    Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0485-2019·2018-11-28

    Tosoh AIA-900 Analyzer Software Issue May Delay Patient Testing

    Tosoh is recalling three AIA-900 immunoassay analyzers due to a software issue that may cause reagent data errors, potentially delaying patient results.

    Product
    Tosoh AIA-900 immunoassay Analyzer
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0496-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling eight units of the Vanguard Knee System because the outer carton labels do not match the inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0494-2019·2018-11-28

    BD Vacutainer Urine Cup Kit Recall for Potential RBC Count Elevation

    Becton Dickinson is recalling BD Vacutainer Urine Cup Kits because they may cause slight red blood cell count elevations when used with specific analyzers.

    Product
    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0458-2019·2018-11-21

    Siemens ARTIS Q Biplane Recalled for C-Arm Vibration Issues

    Siemens is recalling 54 ARTIS Q biplane x-ray systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.

    Product
    ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0468-2019·2018-11-21

    Arrow Multi-Lumen CVC Kit Recalled for Labeling Inconsistencies

    Arrow International is recalling 3,640 units of the AGB+ Multi-Lumen CVC Kit because some labels incorrectly state the spring-wire guide size as .032 instead of .025.

    Product
    Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2019·2018-11-21

    Espiner Tissue Retrieval System Recalled for Incorrect Volume Labeling

    Espiner Medical Ltd is recalling 230 units of the Eco-Sac Tissue Retrieval System because the label incorrectly states the volume is 1200 ml instead of 1000 ml.

    Product
    Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0459-2019·2018-11-21

    Siemens Artis Q.zen Biplane X-Ray System Recalled for C-Arm Vibration

    Siemens Medical Solutions is recalling 15 Artis Q.zen biplane angiographic x-ray systems because C-arm vibrations may reduce image quality.

    Product
    ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0466-2019·2018-11-21

    Siemens Dimension Vista Lipase Reagent Cartridge Recalled for Variability

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Lipase Flex Reagent Cartridges due to lot-to-lot variability in quality control and patient results.

    Product
    Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2019·2018-11-21

    Siemens Lipase Reagent Cartridge Recall for Lot Variability

    Siemens Healthcare is recalling specific lots of Dimension Lipase Flex Reagent Cartridges due to lot-to-lot variability affecting quality control and patient results.

    Product
    Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2019·2018-11-21

    Sandoz Recalls Nitrofurantoin Capsules Due to Cross Contamination

    Sandoz Inc is recalling specific lots of Nitrofurantoin capsules because they may be cross-contaminated with other products.

    Product
    NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS))
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0464-2019·2018-11-21

    Abbott TECNIS Intraocular Lenses Recalled for Expiration Date Violations

    Johnson & Johnson Surgical Vision is recalling 17 expired Abbott TECNIS intraocular lenses distributed in seven US states.

    Product
    Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0457-2019·2018-11-21

    Siemens Artis zee Biplane Systems Recalled for C-Arm Vibration Issues

    Siemens is recalling 14 Artis zee biplane systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.

    Product
    ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0278-2019·2018-11-21

    Taro Recalls Children's Allergy Relief Oral Solution Due to Impurity

    Taro Pharmaceuticals is recalling specific bottles of children's allergy relief oral solution because an unknown impurity exceeded safety limits during routine testing.

    Product
    children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0446-2019·2018-11-21

    BioFire FilmArray Meningitis/Encephalitis Panel Recalled for False Positive Risk

    BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) Panel kits due to a manufacturing issue that may cause elevated rates of false positive results for HSV-1.

    Product
    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0440-2019·2018-11-21

    Medtronic Recalls INFUSE Bone Graft Kits Due to Extra Sponges

    Medtronic is recalling 138 units of INFUSE Bone Graft X Small Kits because they may contain two absorbable collagen sponges instead of one.

    Product
    INFUSE Bone Graft X SMALL KIT REF 7510100
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0455-2019·2018-11-21

    Straumann Recalls Neodent GM Mini Conical Abutments Due to Label Mismatch

    Straumann Manufacturing is recalling 21 units of Neodent GM Mini Conical Abutments because the laser-engraved label does not match the item in the package.

    Product
    Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingiva
    Category
    Medical Device
    Distribution
    Distributed nationwide