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.

11876–11900 of 21617

  • ModerateFDA (Food)·F-3549-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Control Failures

    Kilby Cream is recalling various flavors of ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: Strawberry Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3509-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Production Temperature Deviations

    Kilby Cream is recalling specific sizes of Mootella ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Mootella Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3488-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Almond Delight ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Almond Delight Size: 7 oz. and Gallon
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3497-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Cowconut ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Cowconut Size: 2.5 Gal, Pint
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3500-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviation During Production

    Kilby Cream is recalling Independence Explosion ice cream in 2.5-gallon and 7-ounce sizes because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Independence Explosion Size: 2.5 Gal, 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3550-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling various ice cream flavors because production and storage temperatures were not properly maintained.

    Product
    Kilby Cream Ice Cream Various Flavors: Strawberry Cheesecake Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3552-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviations

    Kilby Cream is recalling various ice cream flavors due to a process deviation where proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: , Tracker Tracks Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3510-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling Oriole Chip ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Oriole Chip Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1165-2017·2017-09-27

    PharMEDium Recalls Fentanyl Citrate Bags Due to Expired Diluent

    PharMEDium Services is recalling 590 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3494-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling 2.5-gallon Cappuccino ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Cappuccino Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3501-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviation

    Kilby Cream is recalling 2.5-gallon Island Breeze ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Island Breeze Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3569-2017·2017-09-27

    Joy's Gourmet Olive Salad Recalled for Unrecorded Temperature Data

    Joy's International Foods is recalling 16 cases of Joy's Gourmet Olive Salad because temperature records were missing after thermal processing.

    Product
    Joy's Gourmet Olive Salad, All Natural, Net Wt. 10 OZ. (280g).
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3120-2017·2017-09-20

    Leica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling four units of Podoplanin (D2-40 Mab) antibody because a delay in transit may have caused the product to be stored outside of required temperature limits.

    Product
    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3126-2017·2017-09-20

    Leica Biosystems Recalls SOX-10 Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling 37 units of SOX-10 (Polyclonal) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue staine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3124-2017·2017-09-20

    Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 Mab.) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3129-2017·2017-09-20

    Fujifilm Endoscope Corrective Action Following FDA Inspection

    Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.

    Product
    Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3116-2017·2017-09-20

    Becton Dickinson Recalls SafetyGlide Needles Due to Foreign Matter

    Becton Dickinson is recalling 1,249,200 units of BD SafetyGlide needles because they contain loose polypropylene foreign matter above release specifications.

    Product
    BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings exte
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-3121-2017·2017-09-20

    Leica Biosystems Recalls Glypican-3 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling three units of Glypican-3 (1G12 Mab) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedde
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3123-2017·2017-09-20

    Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of required temperature ranges.

    Product
    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autoso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3122-2017·2017-09-20

    Leica Biosystems Recalls MiTF Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling 10 units of Microphthalmia Transcription Factor (MiTF) antibody because a transit delay caused the product to be stored outside required temperature ranges.

    Product
    Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively ident
    Category
    Medical Device
    Distribution
    Distributed nationwide