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.

3426–3450 of 3531

  • ModerateFDA (Devices)·Z-2215-2021·2021-08-18

    Support Surface Device Distributed to Home Patients Without Healthcare Professional Instructions

    An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.

    Product
    Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·21771·2021-08-12

    Andecor Girls Soft Tye Dye Area Rugs Recalled for Fire Hazard

    About 375 Andecor Girls Soft Tye Dye Area Rugs sold on Amazon.com fail to meet federal flammability standards for carpets and rugs, posing a fire hazard. Consumers should stop using them immediately and contact And Beyond for a full refund.

    Product
    Andecor Girls Soft Tye Dye Area Rugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·21772·2021-08-12

    Pacapet Fluffy Pink Area Rugs Recalled for Fire Hazard

    Pacapet Fluffy Pink Area Rugs fail to meet federal flammability standards and pose a fire hazard. About 700 rugs sold online at Amazon.com from May 2020 through March 2021 are affected.

    Product
    Pacapet Fluffy Pink Area Rugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2021·2021-08-11

    Beta-Hydroxybutyrate Diagnostic Reagent Recalled for Stability Degradation

    Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.

    Product
    Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0697-2021·2021-08-11

    Global Hand Sanitizer Recalled Due to Denaturant Deficiency

    Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.

    Product
    Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2181-2021·2021-08-11

    Deluxe At-Home ICI Insemination Kit Recalled for Unauthorized Distribution

    Tenderneeds Fertility LLC recalls its Deluxe At-Home ICI Insemination Kit (SKU 636391205856), all lots sold before December 9, 2019, due to distribution without FDA marketing authorization.

    Product
    Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2203-2021·2021-08-11

    In Vitro Diagnostic Reagent Recalled Due to Stability Deterioration

    Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.

    Product
    Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2177-2021·2021-08-11

    FDA Recalls IUI Kit and Metal Speculum for Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.

    Product
    Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2173-2021·2021-08-11

    Amia Automated PD System User Guide Incorrectly Describes Ultrafiltration Limit Function

    Baxter's user guide for the Amia Automated PD System incorrectly describes how the Ultrafiltration Limit setting controls the Extra Last Drain Mode. This documentation error could affect patients' ability to properly end therapy sessions.

    Product
    Sharesource Connectivity Platform for Use with the Amia Automated PD System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0698-2021·2021-08-11

    Global Hand Sanitizer with Moisturizer Recalled for Denaturant Deviation

    Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with Moisturizer due to failure to meet the required denaturant specification. The product was distributed to affiliated facilities and third-party recipients in nine states.

    Product
    Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2172-2021·2021-08-11

    GlideScope Go Video Monitors Recalled for Waterproof Rating Defect

    Verathon recalls GlideScope Go Monitors due to failure to meet IP67 waterproof rating, which may allow fluid ingress and loss of functionality.

    Product
    GlideScope Go Monitors
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Drugs)·D-0700-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity

    Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2168-2021·2021-08-11

    Infant Heel Warmer Instructions Updated for Activation Safety Warning

    ROi CPS LLC is updating instructions for the Regard NEWBORN KIT infant heel warmer (688 units in Missouri) to include a warning: activate away from the face, infant, and others.

    Product
    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0701-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit

    Pfizer is recalling Chantix (varenicline tartrate) 1 mg tablets nationwide because certain lots contain the impurity N-nitroso-varenicline above FDA's acceptable interim intake limit due to manufacturing deviations.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-nitroso-varenicline Impurity

    Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2021·2021-08-11

    Diagnostic Reagent Stability Issues Lead to Out-of-Range Quality Control Values

    Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.

    Product
    Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2202-2021·2021-08-11

    Beta-Hydroxybutyrate diagnostic reagent recalled due to stability degradation

    Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic accuracy.

    Product
    Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2021·2021-08-04

    Contact Lens Axis Mark Misalignment Causes Blurred Vision

    CooperVision's FRESH DAY 1 DAY TORIC contact lenses (lot W0106186) are recalled because misaligned axis marks can cause blurred vision. Affected lenses were distributed worldwide, including in the US, France, Brazil, and other countries.

    Product
    FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2021·2021-08-04

    ThermoScientific Oxoid Antimicrobial Susceptibility Discs Recalled for Out-of-Specification Performance

    Remel Inc. is recalling certain lots of ThermoScientific Oxoid Antimicrobial Susceptibility Discs because they were manufactured out of specification, potentially affecting laboratory test accuracy. The recall involves 327 units distributed nationwide and to Bermuda.

    Product
    ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2021·2021-08-04

    CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106186) due to misaligned placement of the axis mark, which can cause blurred vision.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0869-2021·2021-08-04

    Now Real Food Organic Steel Cut Oats Mislabeled with Wrong Product

    NOW Health Group Inc. is recalling a specific lot of Organic Steel Cut Oats that may contain Organic Beet Sugar instead of the labeled product. Affected consumers should not consume the product.

    Product
    Now Real Food Organic Steel Cut Oats, 2 lb bag, code 6295, UPC 733739062956, packed 8 bags per case; case packaging is for Now Real Food Organic Beet Sugar 3lbs bags
    Category
    Food
    Distribution
    45 states
  • ModerateFDA (Drugs)·D-0695-2021·2021-08-04

    Drug Recall: Estriol USP41 Micro Due to cGMP Deviations

    API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.

    Product
    Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0696-2021·2021-08-04

    Azelaic Acid 99.0+% Micro 500G Drug Recalled for cGMP Deviations

    API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

    Product
    Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Food)·F-0808-2021·2021-08-04

    Del Monte Fresh Cut Golden Sweet Whole Kernel Corn Recall

    Del Monte Foods is recalling Del Monte Fresh Cut Golden Sweet Whole Kernel Corn due to post-process spoilage discovered in some containers during inspection at a distribution center.

    Product
    Del Monte Fresh Cut Golden Sweet Whole Kernel Corn; 15.25 oz. can (24 x 15.25 oz. cans per case) Case UPC  10024000163029 Can UPC - 024000163022 Distributed by Del Monte Foods, Walnut Creek, CA
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Drugs)·D-0690-2021·2021-07-28

    Erythromycin Topical Gel 2% Recalled Due to Failed Impurity Specifications

    Teligent Pharma, Inc. is recalling Erythromycin Topical Gel 2% due to failed impurities and degradation specifications. The recall affects approximately 22,824 tubes distributed nationwide.

    Product
    Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,
    Category
    Drug
    Distribution
    Distributed nationwide