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.

376–400 of 21708

  • 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 (Devices)·Z-2729-2026·2026-07-22

    Orthofix MINIRAIL external fixation devices recalled for incorrect model labeling

    Orthofix U.S. LLC is recalling Orthofix MINIRAIL external fixation devices (Model M101) because they may be labeled with incorrect model numbers, potentially leading to use of wrong device specifications.

    Product
    Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
    Category
    Medical Device
    Distribution
    26 states
  • 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 (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 (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…
    Category
    Food
    Distribution
    28 states
  • 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-2734-2026·2026-07-22

    Papablic Replacement Brush Heads Recalled Due to Breakage Risk

    Papablic Inc is recalling Papablic Replacement Brush Heads (Model PAPA317AA) due to potential for brush heads to break. The recall affects approximately 13,400 packs distributed nationwide.

    Product
    Papablic Replacement Brush Heads. Model Number: PAPA317AA.
    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
  • 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 (Drugs)·D-0687-2026·2026-07-22

    Meijer Earwax Removal Kit Recalled for Subpotent Active Ingredient

    Bell Pharmaceuticals is recalling Meijer Earwax Removal Kit (Carbamide Peroxide 6.5%) due to subpotency: the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, limiting effectiveness.

    Product
    MEIJER EARWAX REMOVAL KIT — MEIJER EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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
  • 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
  • ModerateNHTSA·26V455000·2026-07-15

    2022 Nissan Armada and Infiniti QX vehicles with incorrect GAWR label

    Nissan is recalling certain 2020–2026 Nissan Armada and 2011–2027 Infiniti QX56/QX80 vehicles with 22" wheels because the Gross Axle Weight Rating on the certification label is incorrect, which can allow the vehicle to be overloaded and increase crash risk.

    Product
    INFINITI — INFINITI, NISSAN QX80, ARMADA, QX56
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2700-2026·2026-07-15

    EMPOWR 3D Knee surgical device recalled due to packaging discrepancy

    Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy where incorrect product sizes were mixed up in packaging.

    Product
    Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0663-2026·2026-07-15

    Medline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels

    Medline Remedy Specialized Silicone Cream is being recalled because formaldehyde levels exceeded the product specification. BioMed Laboratories is recalling approximately 509,652 tubes distributed nationwide.

    Product
    MEDLINE — MEDLINE (DIMETHICONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0669-2026·2026-07-15

    Isopropyl Alcohol 70% recalled for subpotency nationwide

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% is recalled nationwide because the product is subpotent. The manufacturer Gasco Industrial Corp. initiated this voluntary recall.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0668-2026·2026-07-15

    Drogueria San Juan Isopropyl Alcohol 70% Recalled for Subpotency

    Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (1 gallon) due to subpotency. The affected lots are 250221A5 and 250224A2 distributed nationwide.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0670-2026·2026-07-15

    Drogueria San Juan Isopropyl Alcohol 70% recalled for subpotency

    Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (32 oz.) due to subpotency. Affected lots 250206B1, 250218B2, and 250507B1 were distributed nationwide in the US.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0665-2026·2026-07-15

    Gasco Isopropyl Alcohol 70% Recalled for Subpotent Drug Content

    Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (16 oz bottles, Lot 250306B3) nationwide because the product is subpotent. Consumers should stop using the affected product and contact their healthcare provider if they have health concerns.

    Product
    Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
    Category
    Drug
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2717-2026·2026-07-15

    Versius Surgical System Console affected by cybersecurity vulnerability

    CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.

    Product
    Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2714-2026·2026-07-15

    OmniTract Surgical Retractor System sterilization instructions require extended dry time

    Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the sterilization instructions require a longer dry time than stated in the current manual. The dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle used.

    Product
    OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2696-2026·2026-07-15

    Medline Convenience Kits containing temperature probes recalled

    Medline Industries is recalling Convenience Kits containing Covidien Mon-a-Therm General Purpose Temperature Probes due to an error in distribution control. The recall affects 75 kits distributed nationwide.

    Product
    Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
    Category
    Medical Device
    Distribution
    Distributed nationwide