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.

2426–2450 of 2769

  • LowFDA (Food)·F-1581-2013·2013-07-10

    Alymaq Extra Fine Granulated Sugar Recalled for Potential Plastic Fragments

    Alymaq Inc is recalling 770 bags of Extra Fine Granulated Sugar AIB in Ohio due to the potential presence of plastic fragments.

    Product
    ALYMAQ EXTRA FINE GRANULATED SUGAR AIB, www.alymaq.com, NET WT. 50 LBS. (22.68KG), KEEP IN A COOL AND DRY PLACE. Multi-wall polyethylene lined bag. 55 bags per pallet.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-1596-2013·2013-07-03

    STERIS Recalls Quick Connects for Labeling Updates

    STERIS Corporation is recalling four Quick Connect products to update labeling and remove obsolete device models.

    Product
    Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, teth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1615-2013·2013-07-03

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because an excess amount of surfactant was unintentionally added during manufacturing.

    Product
    VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-610-2013·2013-07-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,808 bottles of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1568-2013·2013-07-03

    Integra LifeSciences Recalls Ascension CMC Saddle Due to Labeling Discrepancies

    Integra LifeSciences is recalling 467 Ascension CMC Saddle implants because the US Instruction for Use contains content discrepancies compared to the FDA-cleared version.

    Product
    CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1614-2013·2013-07-03

    Ortho-Clinical VITROS Potassium Slides Recalled for Unintentional Surfactant Addition

    Ortho-Clinical Diagnostics is recalling VITROS Potassium Slides because a surfactant was unintentionally added during manufacturing.

    Product
    VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-602-2013·2013-06-26

    Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Lotion Due to Incorrect Formulation

    Mission Pharmacal Co is recalling 8,437 bottles of Sodium Sulfacetamide 10% and Sulfur 5% Lotion because the active ingredients were formulated too high.

    Product
    Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1449-2013·2013-06-26

    Philips BuckyDiagnost Radiographic X-ray System Recalled for Documentation Issues

    Philips Healthcare Inc. is recalling 66 BuckyDiagnost Radiographic X-ray systems because installation acceptance test documentation was missing or inconsistent.

    Product
    Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-604-2013·2013-06-26

    Sheffield Triple Antibiotic Ointment Recalled for Stability Failures

    Faria Limited LLC is recalling Dr. Sheffield's Triple Antibiotic Ointment because it failed stability specifications and could not meet shelf-life requirements.

    Product
    Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Devices)·Z-1552-2013·2013-06-26

    Prism Medical Recalls BC Hammock Mesh Slings Due to Incorrect Size

    Prism Medical Services USA is recalling 10 BC Hammock Mesh Slings (Medium) because they were produced in the incorrect size.

    Product
    BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1554-2013·2013-06-26

    Prism Medical BC Hammock Mesh Sling Recalled for Incorrect Size

    Prism Medical Services USA is recalling 5 BC Hammock Mesh Sling units because they were produced in the incorrect size, failing to meet the firm's standards.

    Product
    BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1550-2013·2013-06-26

    IDEV Technologies Recalls SUPERA VERITAS Stent Due to Outer Labeling Error

    IDEV Technologies is recalling three SUPERA VERITAS stents because of an error on the outer labeling. The inner label was correct.

    Product
    IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1448-2013·2013-06-26

    Philips Diagnost Stationary Radiographic System Recalled for Table Height Non-Compliance

    Philips Healthcare Inc. is recalling 101 units of Diagnost Stationary Radiographic Systems because installation records show table height measurements out of specification.

    Product
    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1447-2013·2013-06-26

    Philips Radiographic Systems Recalled for Non-Compliant Installation Test Documents

    Philips Healthcare is recalling 177 stationary radiographic systems because their Installation Acceptance Test Documents were non-compliant with regulations or could not be located.

    Product
    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1530-2013·2013-06-19

    Berkshire Cheese LLC Recalls Blue Cheese Due to Non-Pathogenic E. Coli Contamination

    Berkshire Cheese LLC is recalling Berkshire Blue Cheese due to non-pathogenic E. Coli contamination. The product was distributed in Massachusetts.

    Product
    Berkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days Unit size: 2-3 Lb. wheels Wrapped in wax paper then plastic
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-599-2013·2013-06-19

    Actavis Recalls Fentanyl Transdermal Systems Due to Impurity Specifications

    Actavis is recalling Fentanyl Transdermal Systems, 50 mcg/h, because they failed impurities and degradation specifications.

    Product
    Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-596-2013·2013-06-12

    Voltaren 1% Gel Recalled for Illegible Lot and Expiration Dates

    Physicians Total Care is recalling 76 tubes of Voltaren 1% Gel because the lot number and expiration date on the tubes may not be legible.

    Product
    Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-576-2013·2013-06-12

    Novartis Recalls Lamisil AT Cream Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Lamisil AT Cream because the lot and expiration dates on the tubes may be illegible.

    Product
    Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-575-2013·2013-06-12

    Novartis Lamisil AT Cream Recalled for Illegible Lot and Expiration Dates

    Novartis is recalling 219,600 tubes of Lamisil AT Cream because the lot and expiration dates may be illegible.

    Product
    Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 00
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1441-2013·2013-06-12

    Optovue iVue Software Recall Due to Inconsistent Color Display

    Optovue, Inc. is recalling iVue software versions 3.0 and 3.1 because color displays for Ganglion Cell Complex thickness are inconsistent across different report types.

    Product
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1477-2013·2013-06-12

    Bion Enterprises IgG Conjugate Recalled for Incorrect Expiration Date Labeling

    Bion Enterprises Ltd is recalling 207 units of IgG Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1479-2013·2013-06-12

    Bion Enterprises IgG FITC Conjugate Recalled for Incorrect Expiration Date

    Bion Enterprises is recalling 504 units of IgG FITC Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-578-2013·2013-06-12

    Teva Recalls Disulfiram Tablets Due to Missing Cotton Coil

    Teva Pharmaceuticals is recalling 68,322 bottles of Disulfiram Tablets USP 250 mg because some packaged bottles are missing a cotton coil.

    Product
    Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
    Category
    Drug
    Distribution
    Distributed nationwide