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.

16351–16375 of 21645

  • ModerateFDA (Devices)·Z-1708-2015·2015-06-10

    Siemens Dimension Vista LOCI TSH Test Recalled for Inaccurate Results

    Siemens is recalling 2,256 units of the Dimension Vista LOCI TSH test due to a defect that may cause falsely low results.

    Product
    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2015·2015-06-10

    Siemens Medical Software Recall for Missing Image Measurements on Printouts

    Siemens Medical Solutions is recalling 167 units of Syngo.via and Syngo.x software because measurements on subsequent images do not appear on printouts.

    Product
    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2402-2015·2015-06-10

    Roche Brothers Berry Nutty Mix Recalled for Undeclared Sulfites

    Northhampton Peanut Company is recalling Roche Brothers Berry Nutty Mix trail mix because it contains undeclared sulfites, a non-allergen.

    Product
    Roche Brothers Berry Nutty Mix trail mix packed in 9 oz. and 20 oz. clear plastic containers
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1710-2015·2015-06-10

    Nidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature

    Nidek Inc is recalling 114 EC-5000 Excimer Laser Corneal Surgery Systems because the multi-stage treatment option in the operator's manual was not approved by the FDA.

    Product
    EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1697-2015·2015-06-10

    Coreva Recalls ActCel Hemostatic Dressing for Unapproved Marketing Claims

    Coreva Health Science is recalling ActCel Hemostatic Dressing because customer literature and websites promoted unapproved uses for controlling bleeding in body cavities.

    Product
    ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2347-2015·2015-06-10

    Cosmo Creations Salted Caramel Puffed Corn Recalled for Sugar Labeling Error

    4 Him Food Group LLC is recalling Salted Caramel Premium Puffed Corn because the nutrition label incorrectly listed zero grams of sugar per serving.

    Product
    Salted Caramel Premium Puffed Corn, Cosmo Creations brand, Nitrogen filled, 3-layer laminate packaging, Net weight 14 oz., UPC 8 51710 00141 8.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1112-2015·2015-06-10

    Teva Recalls Zebeta Tablets Due to Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling 889 bottles of Zebeta (bisoprolol fumarate) 10mg tablets because they failed dissolution specifications during stability testing.

    Product
    Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2015·2015-06-10

    Smiths Medical Recalls BCI Advisor Vital Signs Monitors for Data Errors

    Smiths Medical is recalling 15 BCI Advisor Vital Signs Monitors because their auxiliary serial ports may transmit incorrect data to collection systems.

    Product
    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1713-2015·2015-06-10

    Siemens Factor IX Plasma Reagent Recalled for Inaccurate Low-Range Results

    Siemens Healthcare Diagnostics is recalling Factor IX plasma reagents for the BCS/BCS XP system due to erroneously high results at the lower end of the measuring range.

    Product
    Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2348-2015·2015-06-10

    Invo Coconut Water Recalled for Lack of Required Processing

    Creative Food Concepts is recalling Invo Coconut Water with Pineapple because the product lacks a required 5 log reduction process.

    Product
    Coconut Water with Pineapple, 12 bottles/case, 12 oz (355 mL)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2346-2015·2015-06-10

    Guayaki Yerba Mate Recalled Due to Consumer Complaints of Fermentation and Mold

    Guayaki S.R.P., Inc. is recalling one lot of Guayaki Brand Yerba Mate Revel Berry due to consumer complaints of fermented, slimy, carbonated, or moldy product.

    Product
    Guayaki Brand Yerba Mate - Revel Berry; 16 oz aluminum can, Best By 12SEP16. UPC 6 32432 73777 5 Guayaki Yerba Mate is a high energy infusion made from the leaves of the celebrated South American mate tree. Guayaki S.R. P. Sebastopol, CA 95472 Certified Organic by CCOF…
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1709-2015·2015-06-10

    AMUSA Recalls 0.9% Sodium Chloride Flush Syringes Due to Incorrect Expiration Date

    MRP, LLC dba AMUSA is recalling 200,000 units of 0.9% Sodium Chloride Injection Flush Syringes because the labels display an incorrect expiration date.

    Product
    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1114-2015·2015-06-10

    Fresenius Kabi Recalls KABIVEN IV Bags Due to Amino Acid Labeling Error

    Fresenius Kabi is recalling 5,488 bags of KABIVEN IV solution because the label lists 3.1% amino acids, but the product actually contains 3.3%.

    Product
    KABIVEN — KABIVEN (DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1669-2015·2015-06-03

    Siemens Luminos Agile Max Imaging System Software Recall

    Siemens is recalling 133 Luminos Agile Max imaging systems due to a software defect that causes image loss and connection issues.

    Product
    SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1085-2015·2015-06-03

    Boehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets

    Boehringer Ingelheim Roxane Inc is recalling Acarbose 50 mg tablets because potency was below specification at a 9-month stability time point.

    Product
    ACARBOSE — ACARBOSE (ACARBOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2015·2015-06-03

    Siemens Axiom Luminos dRF Max Recall for Software Data Loss

    Siemens is recalling 133 Axiom Luminos dRF Max imaging systems due to a software defect that can cause acquired images to be deleted, requiring studies to be repeated.

    Product
    SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1645-2015·2015-06-03

    Siemens SOMATOM Emotion 16 CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Emotion 16 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2322-2015·2015-06-03

    Gromex Ground Shrimp Recalled for Undeclared Dyes

    Gromex Inc. is recalling 100 lbs of Ground Shrimp found to contain undeclared and unallowed dyes.

    Product
    Gromex Camaron Molido (Ground Shrimp), Net Wt. 2 oz., packaged in a clear bag, Mexican Products, Importers & Distributors, UPC 690912620108
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1658-2015·2015-06-03

    Siemens Immulite 2000 Water Bottle Recall for Quality Defects

    Siemens Medical Solutions Diagnostics is recalling 186 Immulite 2000 water bottles because the openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1659-2015·2015-06-03

    Siemens Recalls Liquid Waste Bottles for Immulite 2000 Systems

    Siemens Medical Solutions Diagnostics is recalling 231 Liquid Waste Bottles for Immulite 2000 systems due to a quality issue where the opening may be undersized or deformed, preventing the cap from closing securely.

    Product
    Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1660-2015·2015-06-03

    Siemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Accessory Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1644-2015·2015-06-03

    Siemens SOMATOM Emotion 6 CT Scanner Software Recall

    Siemens Medical Solutions is recalling 75 SOMATOM Emotion 6 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1663-2015·2015-06-03

    Siemens Liquid Waste Bottle Kit Recalled for Defective Bottle Openings

    Siemens is recalling Liquid Waste Bottle Kits for Immulite 2000 systems because some bottle openings are undersized or deformed, preventing caps from closing securely.

    Product
    Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states