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.

16301–16325 of 21645

  • ModerateFDA (Devices)·Z-1824-2015·2015-07-01

    CooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging

    CooperSurgical is recalling 9,400 McKesson Medi-Pak Vaginal Speculums because small-sized speculums were incorrectly packaged in bags labeled for medium-sized speculums.

    Product
    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2015·2015-07-01

    Cook Inc. Recalls LapSac Surgical Tissue Pouches Due to Labeling Error

    Cook Inc. is recalling 123,184 LapSac Surgical Tissue Pouches because the labeling includes information not stated in the intended use.

    Product
    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2771-2015·2015-07-01

    Sweetwater Recalls Mixed Berry Electrolyte Water for Coliform Testing

    The Sweetwater Co. is recalling Mixed Berry Flavored Electrolyte Water sold under HyVee, Raleys', and Refreshe brands due to high total coliform testing results.

    Product
    Mixed Berry Flavored Electrolyte bottled Water, sold under brand HyVee, Raleys' Purely Made, and Refreshe. Each bottle is 1 Liter (33.8 Fl. oz.). HyVee brand has the UPC 0 75450 12723 2; Raley's brand has the UPC 0 46567 02874 3; Refreshe has the UCP 0 21130 24209…
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1149-2015·2015-07-01

    Indiana Botanic Gardens Recalls Dr Blue Pain Relieving Gel Due to Blending Issues

    Indiana Botanic Gardens is recalling Dr Blue Pain Relieving Gel because the product may not be uniformly blended, resulting in non-uniform distribution of the active ingredient menthol.

    Product
    Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1826-2015·2015-07-01

    Merit Medical Prelude Pro Sheath Introducer Recalled for Incorrect Dilator Packaging

    Merit Medical Systems is recalling Prelude Pro Sheath Introducers packaged with a 0.035-inch dilator instead of the labeled 0.038-inch size.

    Product
    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1809-2015·2015-07-01

    Teleflex Recalls Lifesaver Manual Resuscitators Due to Potential Intake Port Blockage

    Teleflex Medical is recalling 9,333 units of Lifesaver Single Patient Use Manual Resuscitators because the intake port may be blocked, causing the bag to fail to fill.

    Product
    Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2735-2015·2015-07-01

    Golden Chocolate OREX Recalled for Undeclared Food Colorings

    Golden Chocolate International is recalling Golden Chocolate OREX because it contains undeclared FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40.

    Product
    Golden Chocolate OREX, Net Wt. 1Lb (454 g). Keep Refrigerated. Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2733-2015·2015-07-01

    Golden Chocolate Papaya Recalled for Undeclared Food Colorings

    Golden Chocolate International is recalling 513 lbs of ROGALIK PAPAYA due to undeclared FD&C food colorings. The product was distributed in New York and Pennsylvania.

    Product
    Golden Chocolate ROGALIK PAPAYA, Net Wt. 1Lb. (454 g). Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1823-2015·2015-07-01

    X Spine Systems Recalls Fortex Pedicle Screw System Rods

    X Spine Systems is recalling 75 Fortex Pedicle Screw System Continuous Radius Rods because they measure 45mm instead of the specified 50mm.

    Product
    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1843-2015·2015-07-01

    Siemens IMMULITE 2000 Italian Cypress Allergy Test Recall

    Siemens is recalling specific lots of the IMMULITE 2000 Italian Cypress 3g Allergy test because they fail to meet shelf-life stability specifications.

    Product
    IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2770-2015·2015-07-01

    Sweetwater Recalls Lemon Flavored Electrolyte Water Due to Coliform Testing

    The Sweetwater Co. is recalling Lemon Flavored Electrolyte water sold under four brands due to high total coliform testing results.

    Product
    Lemon Flavored Electrolyte bottled water, sold under brand HyVee, Raleys' Purely Made, Refreshe, and Simple Truth. Each bottle is 1 Liter (33.8 Fl. oz.). HyVee brand has the UPC 0 75450 12722 5; Raley's brand has the UPC 0 46567 02873 6; Refreshe brand has the UPC 0…
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1808-2015·2015-06-24

    AMUSA Sterile Field Flush Syringe Recalled for Incorrect Expiration Date Labeling

    MRP, LLC dba AMUSA is recalling 1,080 units of T/S2 0.9% Sodium Chloride Injection flush syringes due to incorrect expiration date labeling.

    Product
    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1139-2015·2015-06-24

    West-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures

    West-Ward Pharmaceutical Corp. is recalling Fentanyl Citrate Injection due to failed impurities and degradation specifications. The recall covers 14,649 cartons distributed nationwide.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2015·2015-06-24

    Synthes Recalls 3.7mm Cannulated Screws Due to Incorrect Labeling

    Synthes, Inc. is recalling 54 units of 3.7mm Cannulated Locking and Conical Screws because certain lots were found to have been labeled incorrectly.

    Product
    3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1134-2015·2015-06-24

    Allegiant Health Recalls Famotidine Tablets Due to Manufacturing Investigation Failures

    Allegiant Health is recalling specific lots of over-the-counter famotidine tablets because the manufacturer failed to adequately investigate customer complaints.

    Product
    Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1136-2015·2015-06-24

    Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure

    Dr. Reddy's Laboratories is recalling 5,160 bottles of Divalproex Sodium Extended-Release Tablets because they failed to meet dissolution specifications.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2732-2015·2015-06-24

    Driscoll's Strawberries Recalled for Pesticide Naled Exceeding Tolerance

    Driscoll's is recalling fresh strawberries due to pesticide Naled levels exceeding EPA tolerance. Affected products were distributed in the US and Mexico.

    Product
    Fresh Driscoll Strawberries, 8 x 16 oz. clamshell, 4 x 32 oz. clamshell. Keep refrigerated Driscoll's Strawberries, Watsonville, CA
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1140-2015·2015-06-24

    American Health Packaging Recalls Lamivudine and Zidovudine Tablets for Dissolution Failure

    American Health Packaging is recalling 925 cartons of Lamivudine and Zidovudine Tablets USP 150mg/300mg because they failed dissolution specifications.

    Product
    Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2015·2015-06-24

    Biomet Vanguard M Unicondylar Tibial Trial Recalled for Incorrect Etching

    Biomet, Inc. is recalling 27 Vanguard M Unicondylar Tibial Trials because the left and right orientation markings are incorrectly etched on the handle.

    Product
    Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1135-2015·2015-06-24

    Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Divalproex Sodium Extended-Release Tablets because they failed to meet dissolution specifications at the 9-hour time point.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2015·2015-06-24

    CooperSurgical Recalls MILEX OMNIFLEX Diaphragms Due to Packaging Error

    CooperSurgical is recalling 200 units of MILEX OMNIFLEX Diaphragms because size 80 boxes were incorrectly packaged with size 85 diaphragms.

    Product
    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-1145-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is voluntarily recalling specific lots of Amlodipine and Atorvastatin tablets because they contain less active ingredient than labeled.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1146-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain less than the labeled amount of active ingredients.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1725-2015·2015-06-17

    Abbott Alkaline Wash Recall Due to Cap Leaking and Crystallization

    Abbott Laboratories is recalling Alkaline Wash cleaning solution for Abbott Architect analyzers due to product leaking from the cap and crystallization around the cap.

    Product
    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide