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.

9426–9450 of 21595

  • ModerateFDA (Devices)·Z-0838-2019·2019-02-27

    Leica PROVEO 8 Ophthalmic Microscope System Recalled for Software Defects

    Leica Microsystems is recalling 142 PROVEO 8 Ophthalmic Microscope Systems worldwide due to software anomalies that may cause unexpected movement interruptions or delayed function stops.

    Product
    PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0842-2019·2019-02-27

    Smiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads

    Smiths Medical ASD Inc. is recalling arterial blood sampling kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.

    Product
    Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2019·2019-02-27

    Akorn Recalls Clobetasol Propionate Cream Due to Preservative Stability Failure

    Akorn Inc. is recalling specific lots of Clobetasol Propionate Emollient Cream 0.05% because stability testing revealed out-of-specification preservative levels.

    Product
    Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1009-2019·2019-02-27

    Sysco Recalls Fresh Lacinato Kale Due to Temperature Control Failure

    Sysco Charlotte is recalling fresh Lacinato-Tuscan kale because a cooler malfunction may have prevented the product from being held at safe temperatures.

    Product
    Packer KALE FRESH LACINATO-TUSCAN¿
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1010-2019·2019-02-27

    Sysco Recalls Fresh Kumquats Due to Temperature Control Failure

    Sysco Charlotte is recalling fresh kumquats because a cooler malfunction prevented proper temperature holding, potentially compromising food safety.

    Product
    Packer KUMQUAT FRESH¿
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1002-2019·2019-02-27

    Sysco Recalls Chicken of the Sea Crab Meat Due to Temperature Issues

    Sysco Charlotte is recalling Chicken of the Sea Crab Meat Super Lump because a cooler malfunction may have allowed the product to be held at unsafe temperatures.

    Product
    Chicken of the Sea CRAB MEAT SUPER LUMP PSTRZD
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0964-2019·2019-02-27

    Sysco Recalls Cheese Cubes Due to Cooler Malfunction and Temperature Issues

    Sysco Charlotte is recalling Block and Barrel Imperial cheese cubes because a cooler malfunction prevented proper temperature holding, potentially making the food unsafe.

    Product
    Block and Barrel Imperial CHEESE CUBE CHED/SWISS/PEP JCK 3/5 lb blocks
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0957-2019·2019-02-27

    Sysco Recalls Wiebe Cheddar Cheese Due to Temperature Control Failure

    Sysco Charlotte is recalling Wiebe Cheddar Cheese because a cooler malfunction prevented the product from being held at appropriate temperatures, potentially compromising food safety.

    Product
    WIEBE CHEESE CHEDDAR CTTNWOOD RIVER¿1/5 LBS
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0510-2019·2019-02-27

    Tubby Todd Bath Co Dream Cream Recalled for Mold Contamination

    Mariposa Labs LLC is recalling Tubby Todd Bath Co Dream Cream due to mold contamination found during testing.

    Product
    tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560.
    Category
    Consumer Product
    Distribution
    1 state
  • ModerateFDA (Food)·F-0983-2019·2019-02-27

    Sysco Recalls Provolone Cheese Due to Temperature Control Failure

    Sysco Charlotte is recalling Great Lakes Provolone Cheese slices because a cooler malfunction may have allowed the product to be held at unsafe temperatures.

    Product
    Great Lakes CHEESE PROVOLONE SLI .5 OZ
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0903-2019·2019-02-20

    Bundle Organics Chocolate Chip Snack Bars Recalled for Mold

    1908 Brands is recalling Bundle Organics Chocolate Chip snack bars due to the presence of mold. The recall affects 2,781 bars distributed to one consignee.

    Product
    Bundle Organics Bar Chocolate Chip, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0823-2019·2019-02-20

    Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues

    Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.

    Product
    Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0898-2019·2019-02-20

    Bundle Organics Salty Nuts and Seeds Bars Recalled for Mold

    1908 Brands is recalling Bundle Organics Salty Nuts and Seeds snack bars due to the presence of mold. The recall affects specific lots distributed to one consignee.

    Product
    Bundle Organics Bar Salty Nuts and Seeds, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0488-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 206 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, meaning the drug may not release properly.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 1,023 bottles of Cardizem CD (diltiazem hydrochloride) 120 mg capsules because they failed to meet dissolution specifications.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide