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.

426–450 of 3531

  • ModerateFDA (Devices)·Z-0166-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Class II Recall

    Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2025·2024-10-30

    Drug injection product recalled due to manufacturing quality violations

    Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0064-2025·2024-10-30

    Horizon Organic Ultra Pasteurized Heavy Whipping Cream recalled for potential premature spoilage

    Horizon Organic Dairy is recalling approximately 2,956 cases of Ultra Pasteurized Heavy Whipping Cream (BEST BY 10/22/24) distributed across 14 states due to the potential for premature spoilage during shelf life.

    Product
    Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0018-2025·2024-10-30

    Vancomycin Injection Recalled Due to Manufacturing Process Violations

    Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.

    Product
    Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0019-2025·2024-10-30

    Drug Recall: NORepinephrine Injectable Due to Manufacturing Compliance Violations

    Fresenius Kabi Compounding recalls 2,151 bags of NORepinephrine Bitartrate injectable due to manufacturing violations. The voluntary recall affects 125 healthcare accounts nationwide.

    Product
    NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2025·2024-10-30

    Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations

    Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.

    Product
    OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2025·2024-10-30

    Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming

    Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.

    Product
    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·25020·2024-10-24

    PowerBlock Commercial Pro 100 Weight Sets with 5 lb Grip Handles Recalled

    PowerBlock is recalling about 1,845 Commercial Pro 100 weight sets sold with 5 lb grip handles because weight plates above 55 lbs can dislodge during use, posing an impact injury risk.

    Product
    Commercial Pro 100 sold with 5 lb grip handles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0027-2025·2024-10-23

    Rum Nut Ice Cream Recalled Due to Undeclared Yellow 5 and Yellow 6

    Today's Frozen Desserts recalls Rum Nut Ice Cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. The recall affects 1,363 units with expiration dates from June 13 to September 13, 2025.

    Product
    Rum Nut Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0120-2025·2024-10-23

    Medline Heart Overhead Table Pack recalled for incorrect model labeling

    Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.

    Product
    MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0029-2025·2024-10-23

    Premium Grapenut Frozen Dessert Recalled for Undeclared Food Coloring

    Today's Frozen Desserts is recalling Premium Grapenut frozen dessert products sold in Florida due to undeclared Yellow 5 and Yellow 6 food coloring additives not listed on product labels.

    Product
    Premium Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0112-2025·2024-10-23

    Medical imaging system software defect causes incorrect grid overlay display

    Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0032-2025·2024-10-23

    Great Value Mixed Fruits Variety Pack Recalled for Undeclared Food Dye

    Walmart is recalling Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack because FD&C Red No. 3 was not declared on the label. The recall affects 511,164 units distributed nationwide.

    Product
    Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack, 4 oz, 12 Pack
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2025·2024-10-23

    Medical Device Kit Incorrectly Labeled With Wrong Model Number

    Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.

    Product
    MEDLINE KIT CV I II, REF DYNJ906071B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0040-2025·2024-10-23

    Seasoned Sesame and Perilla Leaves Recalled for Undeclared Monosodium Glutamate

    Lemonland Food Corp is recalling Seasoned Sesame Leaves and Seasoned Perilla Leaves due to undeclared monosodium glutamate (MSG). The product was distributed in Washington.

    Product
    Item FLD1000AA, Seasoned Sesame Leaves or Seasoned Perilla Leaves, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Sesame Leaves, Red Pepper Powder, Malt Syrup, Soybean, Wheat, Anchovy, Salt, Carrots, Leeks, Garlic, Onion.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0051-2025·2024-10-23

    El Gallo Azul Processed Cheese Recalled for Non-English Labeling

    El Gallo Azul Cock Brand Queso Procesado processed cheese in 300g metal cans is recalled for non-English labeling. The product was distributed in Oregon.

    Product
    El Gallo Azul Cock Brand Queso Procesado/Processed Cheese 300g packaged in a metal can
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0102-2025·2024-10-23

    Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error

    Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2025·2024-10-23

    Boston Scientific AVVIGO+ Medical Device Grid Overlay Display Error

    Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0033-2025·2024-10-23

    Great Value Cherry Mixed Fruit Recalled for Undeclared Food Colorant

    Walmart is recalling Great Value Cherry Mixed Fruit cups nationwide because FD&C Red No 3 was not declared as an ingredient on the label.

    Product
    Great Value Cherry Mixed Fruit, 4 oz, 4 Count and 12 count plastic cups sealed with clear film.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0011-2025·2024-10-23

    Prescription Dapsone Gel 7.5% Recalled Due to Crystallization

    Viona Pharmaceuticals has voluntarily recalled 2,544 pumps of Dapsone Gel 7.5% (Lot #T400512) due to crystallization. The affected product was distributed in New York.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0093-2025·2024-10-23

    Beckman Coulter Urine Chemistry Controls May Produce False Positive Results

    Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.

    Product
    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0026-2025·2024-10-23

    Rum Raisin Ice Cream Recalled for Undeclared Yellow 5 and Yellow 6

    Today's Frozen Desserts has recalled Rum Raisin ice cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. Approximately 1,363 units are affected.

    Product
    Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0029-2025·2024-10-16

    Aligned Medical Septo Pack recalled for containing component under FDA recall

    The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.

    Product
    Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2025·2024-10-16

    iCast Covered Stent Recalled for Unique Device Identifier Labeling Error

    Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.

    Product
    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2025·2024-10-16

    Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch

    Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.

    Product
    Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide