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.

1826–1850 of 21588

  • ModerateFDA (Devices)·Z-2019-2025·2025-07-09

    ARTIS angiography systems may incorrectly report a high radiation dose

    ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2070-2025·2025-07-09

    HemoCue glucose microcuvettes experienced transit time outside of specified limits

    Four boxes of HemoCue Glucose 201 Microcuvettes are being recalled because transit time fell outside limits, so stability through the microcuvette lifetime can no longer be guaranteed.

    Product
    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0070-2025·2025-07-02

    Big O' Smokehouse Whitefish Spread recalled for plastic contamination

    Big O' Smokehouse is recalling 4lb and 8oz containers of Whitefish Spread due to white plastic fragments found in the product. The affected spread was distributed to retail stores and distributors in Michigan and Illinois.

    Product
    Big O' Smokehouse 4lb Whitefish Spread Big O' Smokehouse 8oz Whitefish Spread Packaged in plastic containers
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0489-2025·2025-07-02

    Dobutamine Injection Recall Due to Discoloration and Cracked Vials

    Pfizer is recalling one lot of Dobutamine Injection (250 mg/20 mL) nationwide due to discoloration and discolored solution caused by cracked vials. Healthcare facilities should quarantine and return affected units.

    Product
    DOBUTAMINE — DOBUTAMINE (DOBUTAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0092-2025·2025-07-02

    Super ProTHIN Plus Dietary Supplement Recalled for Undeclared Dyes

    Preventics, Inc. dba Legere Pharmaceuticals is recalling Super ProTHIN Plus dietary supplement because gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) food colorings.

    Product
    Super ProTHIN Plus, dietary supplement. Seven Packets with 2 tablets & 4 Capsules and 1 packet with 14 Nutrilean capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2025·2025-07-02

    Caphosol Artificial Saliva sachets recalled for out-of-specification stability

    Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.

    Product
    Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0060-2025·2025-07-02

    Madeline's Patisserie Butter Croissant Buns recalled for undeclared wheat

    Element 112, LLC is recalling Madeline's Patisserie 4.25 Inch Butter Croissant Buns because they contain undeclared wheat, a major food allergen.

    Product
    Madeline's Patisserie 4.25 Inch Butter Croissant Bun, Net Wt. 4 lbs. 6 oz (1,984.47 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·H-0090-2025·2025-07-02

    Nootri Toto food product recalled due to insanitary conditions

    East Africa Boutique, LLC is recalling Nootri Toto (1 kg packages) distributed to seven retailers in Indiana, Kentucky, Missouri, and Ohio due to products being held under insanitary conditions.

    Product
    Nootri Toto, Net Weight 1 kg, packaged in a cardboard box, packed 12 boxes per case
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·H-0094-2025·2025-07-02

    Probese Caps dietary supplement recalled for undeclared food dyes

    Probese Caps, a dietary supplement with Iron sold in 90-count bottles, is being recalled because it contains undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules.

    Product
    Probese Caps, dietary supplement with Iron. 90-count bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2009-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw labeling mismatch recall

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Drugs)·D-0483-2025·2025-07-02

    Tirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance

    Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.

    Product
    Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0093-2025·2025-07-02

    Protrim Plus Dietary Supplement Recall for Undeclared Food Dyes

    Protrim Plus dietary supplement 90-capsule bottles contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules. The product was distributed nationwide and may pose a risk to consumers with dye sensitivities or allergies.

    Product
    Protrim Plus, dietary supplement. 90 capsule/bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1998-2025·2025-07-02

    LUCAS Chest Compression System demonstration units recalled

    Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression system demonstration units that may have been provided to customers for clinical use instead of demonstration purposes only.

    Product
    LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0088-2025·2025-07-02

    Carley's Soft Baked Iced Lemon Cookies recalled for misbranded color

    Carley's Inc. is recalling Soft Baked Iced Lemon Cookies because the label incorrectly identifies an artificial yellow color instead of listing it as FD&C Yellow #5 as required.

    Product
    Carley s Soft Baked Iced Lemon Cookies, 5.34oz Plastic Tray, clear film overwrap w/ Label, 12 units per case
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2026-2025·2025-07-02

    Jewel Precision Reusable Rigid Sterilization Container System Instructions Mismatch

    Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2027-2025·2025-07-02

    Atellica CH Diluent Contaminated with Sodium Hypochlorite

    Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.

    Product
    Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2025·2025-07-02

    Medline Umbilical Tray sterile packaging defect recall

    Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.

    Product
    Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2011-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw package labeling mismatch

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·H-0059-2025·2025-07-02

    Madeline's Patisserie Raspberry Croissants Recalled for Undeclared Wheat

    Element 112, LLC is recalling Madeline's Patisserie Raspberry Croissants because they contain undeclared wheat, a major allergen. The recall affects approximately 194 cases distributed to four distributors in Michigan and Ohio.

    Product
    1) Madeline's Patisserie 2.5 ounce Raspberry Croissant, Net Wt. 4 lbs. (1,814.37 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case 2) Madeline's Patisserie 3.5 ounce Raspberry Croissant, Net Wt. 6 lbs. 10 oz. (3,005.05 g), packaged in a
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2033-2025·2025-07-02

    Jewel Precision Sterilization Container System Recalled for FDA Non-Clearance

    Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·H-0089-2025·2025-07-02

    Super Cereal Plus fortified corn soya blend recalled for insanitary conditions

    East Africa Boutique, LLC. is recalling Super Cereal Plus fortified corn soya blend (1.5 kg bags) distributed to retailers in four states because the products were held under insanitary conditions.

    Product
    Super Cereal Plus fortified corn soya blend, Net Weight 1.5 kg, packaged in a plastic foil bag, packed 9 bags per case
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·H-0072-2025·2025-07-02

    Nature Mills Sesame Rice Mix recalled for undeclared milk allergen

    NatureMills US Incorporated is recalling Nature Mills Sesame Rice Mix, 200g, due to undeclared milk. The product was distributed in the USA via the firm's website.

    Product
    Nature Mills Sesame Rice Mix, 200g
    Category
    Food
    Distribution
    0 states