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.

11501–11525 of 21617

  • ModerateFDA (Devices)·Z-0384-2018·2018-01-24

    Valeant Recalls SPAG-2 Nebulizers for Particle Size Failures

    Valeant Pharmaceuticals is recalling 418 SPAG-2 units and 808 nebulizers because some units failed to meet particle size specifications for ribavirin aerosol administration.

    Product
    Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0593-2018·2018-01-24

    Ventura Foods Recalls Sysco Imperial Glazed Hot Bacon Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling Sysco Imperial Glazed Hot Bacon Dressing because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Sysco Imperial Glazed Hot Bacon Dressing; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: B12917
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0338-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0591-2018·2018-01-24

    Ventura Foods Recalls Gordon Choice Thousand Island Dressing Due to Plastic Contamination

    Ventura Foods is recalling specific lots of Gordon Choice Thousand Island Dressing because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Gordon Choice Thousand Island Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ; Code: B33217.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0347-2018·2018-01-24

    Stryker Recalls Trevo XP ProVue System Due to Carton Mismatch

    Stryker Neurovascular is recalling one Trevo XP ProVue System kit because the carton sleeve did not match the physical contents of the pack.

    Product
    Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0601-2018·2018-01-24

    Ventura Foods Recalls Rio Pacific Deluxe BBQ Sauce Due to Plastic Foreign Object

    Ventura Foods, LLC is recalling Rio Pacific Foods Deluxe BBQ Sauce because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Rio Pacific Foods Deluxe BBQ Sauce; 3.78 litre; Produced in the USA for Funnybones Foodservice Ltd, Hertfordshire AL7 1HW; Lot #120117
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2018·2018-01-24

    Shiseido Recalls bareMinerals Sunscreen Lotion Due to GMP Deviations

    Shiseido America Inc. is recalling bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0600-2018·2018-01-24

    Ventura Foods Recalls Smokehouse 220 Barbecue Sauce Due to Plastic Foreign Object

    Ventura Foods is recalling Smokehouse 220 Sweet & Spicy Barbecue Sauce because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Smokehouse 220 Sweet & Spicy Barbecue Sauce; Net Wt. 16 OZ.; Ventura Foods, Brea, CA 92823; Coded: 05 30 18.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0597-2018·2018-01-24

    Ventura Foods Recalls House Recipe Ranch Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling 117 cases of House Recipe Ranch Dressing & Dip because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    plastic cup with foil seal: House Recipe Ranch Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Code: B10127; packed in cardboard case : House Recipe; Distributed By Sysco Corporation; Houston Texas 77077; B10127; HR Rch 128/1.5 oz; 30
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0594-2018·2018-01-24

    Ventura Foods Recalls Tartar Sauces Due to Plastic Foreign Object

    Ventura Foods is recalling specific lots of Imperial, Classic Gourmet, and Culinary Secrets tartar sauces because a plastic foreign object was introduced into the product stream.

    Product
    Sysco Imperial Tartar Sauce; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: 12817; Classic Gourmet Dressings Select Tartar Sauce; Net Contents 1 Gal.; Ventura Foods, Brea, CA 92821; Code 05 30 18; . Culinary Secrets Deluxe Tartar Sau
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2018·2018-01-24

    TEI Biosciences Recalls PriMatrix Acellular Dermal Tissue Matrix Due to Labeling Errors

    TEI Biosciences is recalling 4,081 units of PriMatrix acellular dermal tissue matrix because some Instructions for Use contained missing or duplicate pages.

    Product
    PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0349-2018·2018-01-24

    Zimmer Biomet Recalls Persona Partial Knee Finishing Guides

    Zimmer Biomet is recalling 158 Persona Partial Knee System Size 8 Finishing Guides because they may not adequately account for shape differences, potentially causing additional surgery time or knee tightness.

    Product
    Persona Partial Knee System, Size 8, Finishing Guide
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-0756-2018·2018-01-24

    Paris Foods Recalls Seasoning Blend Due to Pesticide Residue Risk

    Paris Foods Corporation is recalling a specific lot of seasoning blend because it may be contaminated with a chemical pesticide residue.

    Product
    Seasoning Blend- S.E. Meats (Diced red peppers, green peppers, celery and onions) Net weight 1300 LB in TOTE (Plastic liner, corrugated totes)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0337-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 120 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0341-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error

    Spineart SA is recalling 15 units of Tryptik 2 C-Plate Self Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0334-2018·2018-01-24

    DeRoyal Recalls Sterile Surgical Kits Due to Expired Prep Pads

    DeRoyal is recalling 226 sterile surgical kits because the included povidone iodine prep pads do not support the 36-month expiration date listed on the label.

    Product
    DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-86
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0186-2018·2018-01-17

    KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Labeling Errors

    KRS Global Biotechnology is recalling 963 bags of Oxytocin 30 Units IV solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0209-2018·2018-01-17

    Prinston Recalls Valsartan Tablets Due to Physical Specification Failures

    Prinston Pharmaceutical Inc. is recalling 21,987 bottles of Valsartan 160 mg tablets because customer complaints confirmed the tablets were thicker and heavier than specifications.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0213-2018·2018-01-17

    Dr. Reddy's Recalls Docetaxel Injection Vials Due to Seal Defects

    Dr. Reddy's is recalling 1,051 vials of Docetaxel Injection USP due to defects in the vial seals that may allow the stopper to detach.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2018·2018-01-17

    Brainlab DrapeLink Adapter Recall Due to Manufacturing Error

    Brainlab AG is recalling DrapeLink Adapters because a supplier error caused some units to not meet specifications.

    Product
    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0205-2018·2018-01-17

    KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 5,786 vials of Vitamin 10 B Lyophilized Vial due to incorrect or missing lot and expiration dates.

    Product
    Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0207-2018·2018-01-17

    KRS Global Biotechnology Recalls 7-Keto DHEA Capsules Due to Labeling Error

    KRS Global Biotechnology is recalling 7-Keto DHEA 25mg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0180-2018·2018-01-17

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 1,009 vials of Hydroxocobalamin 0.5 mg/mL because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0176-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 2,239 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide