The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

1901–1925 of 2769

  • LowFDA (Devices)·Z-2432-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Urine Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Urine Specimen Collection Kits because some lots contain a sub-component with an expiration date earlier than the kit's expiration date.

    Product
    Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1350-2015·2015-08-26

    Qualitest Recalls Ampicillin Capsules Due to Unapproved Labeling

    Vintage Pharmaceuticals LLC is recalling 360 bottles of Ampicillin Capsules, USP, 250 mg, because they are labeled with unapproved labeling.

    Product
    AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2434-2015·2015-08-26

    BD Vacutainer SST Plus Blood Collection Tubes Recalled for Stopper Defects

    Becton Dickinson & Company is recalling specific lots of BD Vacutainer SST Plus Blood Collection Tubes because some stoppers were manufactured with a reduced cycle cure time.

    Product
    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-2419-2015·2015-08-26

    Getinge 86 Series Washer/Disinfector Recalled for Remote Access Vulnerability

    Getinge Disinfection AB is recalling 20 Model 8666 and 8668 washer/disinfectors due to a potential for unauthenticated remote network access.

    Product
    Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Devices)·Z-2431-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Vaginal and Endocervical Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Vaginal/Endocervical Specimen Collection Kits because some lots contain a sub-component with an earlier expiration date than the kit itself.

    Product
    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1345-2015·2015-08-26

    Sun Pharma Recalls Bupropion Hydrochloride Tablets for Dissolution Failure

    Sun Pharma Global Fze is recalling 35,235 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed to meet drug release specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2951-2015·2015-08-19

    Mason Vitamins Recalls Mislabeled Coenzyme Q-10 50 mg Softgels

    Mason Vitamins, Inc. is recalling 13,027 bottles of Coenzyme Q-10 50 mg softgels because some bottles were mislabeled with the wrong dosage.

    Product
    Coenzyme Q-10 50 mg label reads in part, "***Major***CO Q-10 50 MG***For healthy HEART & IMMUNE function***Promotes ENERGY in all Body Cells***Dietary Supplement 30 SOFTGELS***."
    Category
    Food
    Distribution
    31 states
  • LowFDA (Drugs)·D-1285-2015·2015-08-12

    Actavis Recalls Desmopressin Acetate Tablets with Incorrect Imprint

    Actavis is recalling 11,445 bottles of Desmopressin Acetate Tablets because some tablets are incorrectly imprinted with an X.

    Product
    Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1286-2015·2015-08-12

    Perrigo Recalls Subpotent Mometasone Furoate Ointment Tubes Nationwide

    Perrigo Israel Pharmaceuticals is voluntarily recalling 158,268 tubes of Mometasone Furoate Ointment USP, 0.1%, because the product is subpotent.

    Product
    Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2264-2015·2015-08-12

    Medtronic Recalls EnVeo R Loading Systems Due to Particulate Presence

    Medtronic is recalling EnVeo R Loading Systems because of the presence of particulate. The recall affects 6,912 units worldwide, including 540 in the US.

    Product
    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2348-2015·2015-08-12

    Zimmer Surgical Recalls Tourniquet Cuffs Due to Missing Instructions

    Zimmer Surgical Inc. is recalling 61 units of 18-inch disposable tourniquet cuffs because the folded instructions for use pamphlet was missing usage instructions and warnings.

    Product
    18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tournique
    Category
    Medical Device
    Distribution
    45 states
  • LowFDA (Drugs)·D-1287-2015·2015-08-12

    GlaxoSmithKline Recalls Panadol Acetaminophen Extra Strength for Dissolution Failures

    GlaxoSmithKline is recalling Panadol Extra Strength acetaminophen bottles in Puerto Rico and the Virgin Islands because the product failed dissolution specifications.

    Product
    Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Devices)·Z-2240-2015·2015-08-05

    EXP Recalls 6.0mm Round Fluted Bur Due to Registration Deficiencies

    EXP Pharmaceutical Services Corp is recalling 5 units of 6.0mm Round Fluted Bur Soft Touch because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-2279-2015·2015-08-05

    Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.

    Product
    Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2276-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiological Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vanco
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2322-2015·2015-08-05

    Acon Recalls Mission Breath Alcohol Detector Kits for Labeling Amendment

    Acon Laboratories is recalling 1,283 Mission Breath Alcohol Detector kits due to a labeling amendment. The devices are distributed nationwide.

    Product
    Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2201-2015·2015-07-29

    Myoscience iovera Smart Tip Recalled for Incorrect Expiration Date Labeling

    Myoscience Inc. is recalling iovera 155 Smart Tips because the expiration dates on the outer boxes and pouches are incorrect.

    Product
    iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1278-2015·2015-07-29

    Purdue Pharma Recalls Intermezzo Sublingual Tablets for Dissolution Failures

    Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.

    Product
    Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2192-2015·2015-07-29

    Hardy Diagnostics Recalls HardyCHROM VRE Agar Due to Lack of Clearance

    Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.

    Product
    HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2090-2015·2015-07-22

    BD Biosciences Recalls Flow Cytometers for Missing Laser Safety Labeling

    BD Biosciences is recalling 2,188 flow cytometers installed between June 2007 and September 2011 because they lack required FDA laser safety labeling.

    Product
    BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1238-2015·2015-07-22

    Geritrex Recalls Carb-O-Philic 40 Cream Due to Container Closure Deviation

    Geritrex Corp is recalling Carb-O-Philic 40 Cream due to a CGMP deviation involving poor container closure of the bulk storage container.

    Product
    Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2066-2015·2015-07-22

    Tosoh Glycohemoglobin Analyzer Buffer Recalled for Incorrect Expiration Date Labeling

    Tosoh Bioscience is recalling G7 Variant Elution Buffer HiS no. 1 (M) because it is labeled with an expiration date of October 2015 instead of the correct October 2014.

    Product
    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1239-2015·2015-07-22

    Qualitest Recalls HydrOXYzine Tablets Due to Unreadable Identification Codes

    Qualitest Pharmaceuticals is recalling HydrOXYzine Hydrochloride 25 mg tablets because some identification codes are unreadable.

    Product
    HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
    Category
    Drug
    Distribution
    Distributed nationwide