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.

9851–9875 of 21617

  • ModerateFDA (Food)·F-0033-2019·2018-10-24

    Coca-Cola Bottling Company Recalls Diet Coke for Plastic Contamination

    Coca-Cola Bottling Company is recalling Diet Coke 12 fl oz bottles because the product contains plastic material. The recall affects shipments to six states.

    Product
    NO SUGAR NO CALORIES Diet Coke 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 495940 3
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0123-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0077-2019·2018-10-24

    Rexall Nasal Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to CGMP deviations that could impact product quality.

    Product
    Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0055-2019·2018-10-24

    Product Quest Recalls OCEAN Saline Nasal Spray Due to Quality Deviations

    Product Quest Manufacturing LLC is recalling OCEAN Saline Nasal Spray bottles nationwide because they were manufactured under conditions that could impact product quality.

    Product
    OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Divis
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 10 units of Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0146-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 78 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0023-2019·2018-10-24

    Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Humco Holding Group, Inc. is recalling Thyroid, USP (Porcine) powder because it has inconsistent levels of levothyroxine and liothyronine.

    Product
    Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2019·2018-10-24

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Recall

    Terumo is recalling 152 Advanced Perfusion System 1 Electronic Patient Gas Systems because the service manual was not updated for software version 1.30.

    Product
    Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0079-2019·2018-10-24

    Finafta Baby Oral Gel Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Finafta Baby Oral Gel because it was manufactured under conditions that could impact product quality.

    Product
    Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2019·2018-10-24

    Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.

    Product
    Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0189-2019·2018-10-24

    Siemens Recalls Atellica Sample Handler Prime Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime software versions 1.13 and lower due to five identified behavioral issues affecting diagnostic testing.

    Product
    Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0036-2019·2018-10-24

    Saline Nasal Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Discount Drug Mart and Food Fair Saline Nasal Spray due to manufacturing deviations that could impact product quality.

    Product
    Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0121-2019·2018-10-24

    CryoLife Pulmonary Hemi-Artery Graft Recalled for Labeling Error

    CryoLife, Inc. is recalling one CryoPatch SG Pulmonary Hemi-Artery graft because the conduit and branch lengths were switched on the product labeling.

    Product
    CryoPatch SG Pulmonary Hemi-Artery, 1 graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2019·2018-10-24

    CVS Saline Nasal Gel Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling CVS Health Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.

    Product
    CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0036-2019·2018-10-24

    K.B. Pizza Recalls Son of Italy Pizza Kits Due to Temperature Abuse

    K.B. Pizza, Inc. is recalling Son of Italy pizza kits because they were left at room temperature for 24 hours.

    Product
    Son of Italy Pepperoni Pizza Kit ,39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0168-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 10 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2019·2018-10-24

    Product Quest Recalls Saline Nasal Mist Due to Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling 46,056 cans of FAMILY wellness Sterile Saline Nasal Mist because they were manufactured under conditions that could impact product quality.

    Product
    FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0054-2019·2018-10-24

    TopCare Saline Nasal Gel Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling TopCare Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.

    Product
    TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0030-2019·2018-10-24

    CVS Health Saline Nasal Mist Recalled for Quality Control Issues

    Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.

    Product
    CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Pro
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0073-2019·2018-10-24

    CVS Triple Antibiotic Ointment Spray Recalled for Low Bacitracin Zinc Levels

    Product Quest Manufacturing LLC is recalling CVS Health Triple Antibiotic Ointment Spray because the bacitracin zinc ingredient was found to be subpotent.

    Product
    CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0114-2019·2018-10-24

    Siemens ADVIA Centaur CKMB Calibrator Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling 69 kits of ADVIA Centaur CKMB Calibrator 2-pack Japan due to a potential bias identified compared to internal standards.

    Product
    ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0035-2019·2018-10-24

    Son of Italy Cheese Pizza Kits Recalled for Temperature Abuse

    K.B. Pizza, Inc. is recalling Son of Italy Cheese Pizza Kits because they were left at room temperature for 24 hours.

    Product
    Son of Italy, Twin Pack Cheese Pizza Kit, 39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0132-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide