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.

101–125 of 21557

  • ModerateFDA (Devices)·Z-2743-2026·2026-07-22

    Photera 600 Phototherapy Device UV Sensor Calibration Error

    Daavlin Distributing Company is recalling 26 Photera 600 phototherapy devices nationwide because the UV sensor gain calibration is incorrect, causing inaccurate ultraviolet output readings.

    Product
    Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1152-2026·2026-07-22

    Liquid Hope Organic Meal Replacement Formula Subpotent Vitamin A Recall

    Nutricia North America is recalling Liquid Hope Organic Whole Foods Meal Replacement Peptide Formula Berry Medley because the product contains less vitamin A than labeled. A testing laboratory used an incorrect method that overstated the vitamin A concentration.

    Product
    functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2
    Category
    Food
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-0683-2026·2026-07-22

    Family Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug

    Family Wellness Carbamide Peroxide 6.5% earwax removal kits are being recalled because they are subpotent with low pH and significantly reduced active ingredient content (approximately 0.6% versus the expected 6–7%). Consumers should stop using affected lots and consult their pharmacist.

    Product
    FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB — FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0682-2026·2026-07-22

    Audiologist's Choice Carbamide Peroxide Earwax Removal Recalls

    Bell Pharmaceuticals is recalling Audiologist's Choice Carbamide Peroxide earwax removal product due to subpotency: the active ingredient concentration is approximately 0.6% instead of the expected 6–7%, and the product has low pH.

    Product
    AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM — AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0685-2026·2026-07-22

    Leader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency

    Bell Pharmaceuticals is recalling Leader Carbamide Peroxide 6.5% Earwax Removal Kit due to subpotency—the active ingredient is significantly reduced (approximately 0.6% versus the expected 6–7%) and the pH is low.

    Product
    LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB — LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1153-2026·2026-07-22

    Nutricia NOURISH Organic Meal Replacement Powder Recalled for Low Vitamin A

    Nutricia North America is recalling its NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY because testing showed the product contains less vitamin A than the label states. A laboratory error led to inaccurate test results that overstated the actual vitamin A concentration in the product.

    Product
    functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8, package UPC 8 57858 00447 2
    Category
    Food
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-2732-2026·2026-07-22

    Orthofix MINIRAIL External Fixation Devices Incorrectly Labeled

    Orthofix MINIRAIL unilateral external fixation devices may be labeled with incorrect model numbers. Three model variants (M101, M103, M122) were mislabeled during manufacturing.

    Product
    Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2736-2026·2026-07-22

    Medline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects

    Medline is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal nonconformities that may compromise sterility. The defect could require extended surgery time to locate an alternative device.

    Product
    Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1174-2026·2026-07-22

    Amy's Organic Lentil Soup Recalled for Potential Spoilage Risk

    Amy's Kitchen is recalling Amy's Organic Soups Lentil Light in Sodium (14.5 oz cans) due to potential for spoilage. The recall affects approximately 15,350 cases distributed across multiple U.S. states and Canada.

    Product
    Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ. (411 g) Microwave: Place soup in a microwave-safe bowl. Cover. Cook for 1.5-2 minutes. Let sit 1 minute. Stir. Serve. Stovetop: Heat soup in a saucepan, stirring occasionally. AMY'S KITCHEN, INC. P.O. BOX 7129 PETAL
    Category
    Food
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2744-2026·2026-07-22

    Photera 600 3-D phototherapy device UV sensor calibration error recall

    Daavlin Distributing Company is recalling Photera 600 3-D phototherapy devices because the UV sensor gain calculation is incorrect, causing inaccurate ultraviolet output measurement.

    Product
    Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2731-2026·2026-07-22

    Orthofix Articulated Minirail Fixator devices recalled for incorrect labeling

    Orthofix U.S. LLC is recalling Articulated Minirail Fixator external fixation devices due to incorrect model labeling. Three models were mislabeled: M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111.

    Product
    Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Drugs)·D-0688-2026·2026-07-22

    CAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient

    CAREone Earwax Removal Drops (Carbamide Peroxide 6.5%) are recalled because the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, making it ineffective.

    Product
    CAREONE EARWAX REMOVAL DROPS — CAREONE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0679-2026·2026-07-22

    Clinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide

    Bell Pharmaceuticals is recalling Clinere Ear Wax Remover nationwide because the product contains significantly reduced active ingredient and low pH. The affected lots were distributed throughout the United States.

    Product
    CLINERE EAR WAX REMOVER — CLINERE EAR WAX REMOVER (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0678-2026·2026-07-22

    CVS Health Earwax Removal Drops Recalled for Subpotent Active Ingredient

    CVS Health Earwax Removal Drops are being recalled because the product contains significantly reduced active ingredient (approximately 0.6% instead of the expected 6–7%) and has low pH. The recalled product may not work as intended.

    Product
    CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID — CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0680-2026·2026-07-22

    Quality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall

    Bell Pharmaceuticals is recalling Quality Choice Earwax Removal Kit (Carbamide Peroxide 6.5%) due to subpotent drug content, with assay levels significantly reduced (approximately 0.6% versus expected 6–7%) and low pH levels.

    Product
    QUALITY CHOICE EARWAX REMOVAL KIT — QUALITY CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2733-2026·2026-07-22

    Papablic Replacement Brush Heads Recalled for Potential Breakage

    Papablic Inc is recalling certain Papablic18B replacement brush head packs because the brush heads may break during use.

    Product
    Papablic Replacement Brush Heads. Model Number: Papablic18B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2722-2026·2026-07-22

    da Vinci SP Instrument Arm Drape may detach during surgical procedures

    Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because the drape rings may detach, exposing the instrument arm and potentially delaying procedures. The recall affects 11,113 units distributed worldwide.

    Product
    da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2737-2026·2026-07-22

    Medline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled

    Medline Industries is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal defects that risk sterility breach during surgical procedures.

    Product
    Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0686-2026·2026-07-22

    Foster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength

    Bell Pharmaceuticals recalls Foster & Thrive Carbamide Peroxide 6.5% due to subpotent drug substance with low pH and significantly reduced assay levels. Approximately 31,094 units distributed nationwide are affected.

    Product
    Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2742-2026·2026-07-22

    Photera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration

    Daavlin Distributing Company is recalling the Photera 400 phototherapy device because the UV sensor calibration is calculating incorrectly, resulting in lower output levels than intended.

    Product
    Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0684-2026·2026-07-22

    Good Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency

    Bell Pharmaceuticals is recalling Good Neighbor Pharmacy Earwax Removal (Carbamide Peroxide 6.5%) due to subpotency—the active ingredient concentration is significantly reduced from expected levels, and the product has a low pH.

    Product
    GOOD NEIGHBOR PHARMACY EARWAX REMOVAL — GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·26618·2026-07-16

    Panasonic Electric Toaster Ovens Recalled for Shock and Fire Hazards

    Panasonic is recalling about 11,480 Model NB-G200 Electric Toaster Ovens because the power cord insulation may be insufficient, posing a shock and fire risk. No fires or injuries have been reported, but four consumers reported tripped circuit breakers.

    Product
    Electric Toaster Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2026·2026-07-15

    5008X Blood Tubing Set connection errors FDA Class II recall

    Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.

    Product
    5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF St
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0664-2026·2026-07-15

    Methohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide

    QuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL compounded drug vials due to failed impurities and degradation specifications. The recall affects multiple lot numbers distributed nationwide.

    Product
    Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2697-2026·2026-07-15

    Medline Open Heart Peds Pack Convenience Kits Temperature Probe Recall

    Medline Industries is recalling specific lots of Open Heart Peds Pack Convenience Kits containing Covidien Mon-a-Therm temperature probes due to a distribution control process error.

    Product
    Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C
    Category
    Medical Device
    Distribution
    Distributed nationwide