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.

2151–2175 of 2769

  • LowFDA (Devices)·Z-2120-2014·2014-08-20

    Nidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label

    Nidek Inc is recalling 567 GYC-1000 Green Laser Photocoagulator systems because the required laser aperture label was not applied to the devices.

    Product
    GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2154-2014·2014-08-13

    Teleflex Recalls RUSCH Foley Urinary Catheter Insertion Trays Due to Labeling Error

    Teleflex Medical is recalling 720 RUSCH Foley Urinary Catheter Insertion Trays because the expiration date is incorrectly printed as the same as the manufacturing date.

    Product
    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2142-2014·2014-08-13

    Carestream Recalls INSIGHT Dental Film Due to Indicator Dot Misplacement

    Carestream Health Inc. is recalling INSIGHT Dental Film because the indicator dot on the packaging is misaligned, which may cause dental practitioners to view images upside down.

    Product
    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2143-2014·2014-08-13

    Carestream Recalls Ultra-speed Dental Film Due to Indicator Dot Misalignment

    Carestream Health Inc. is recalling 1,633 boxes of Ultra-speed Dental Film because the indicator dot is incorrectly positioned, which may cause image orientation errors.

    Product
    Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1516-2014·2014-08-13

    Novartis Recalls Cataflam Tablets Due to Illegible Ink Identification

    Novartis is recalling 50 bottles of Cataflam (diclofenac potassium) 50 mg tablets because ink identification rubbed off during transit, making them illegible.

    Product
    Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·051-2014·2014-08-09

    Oberto's Recalls Chicken Strips Due to Quality Control Issues

    Oberto's Brands is recalling approximately 57,578 pounds of chicken strips due to a company quality issue involving increased water activity.

    Product
    Recall Notification Report 051-2014
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2128-2014·2014-08-06

    Septodont Recalls Self-Etch Bond Adhesive Due to Packaging Error

    Septodont is recalling Self-Etch bond adhesive because the material was incorrectly packaged. The recall involves 60 units distributed to two wholesalers in Pennsylvania and New York.

    Product
    Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2133-2014·2014-08-06

    Siemens Dimension Integrated Chemistry Systems Recalled for Photometer Misassembly

    Siemens is recalling 15 Dimension Integrated Chemistry Systems due to a photometer misassembly issue that may shorten the life of the source lamp.

    Product
    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Drugs)·D-1485-2014·2014-08-06

    Pfizer Recalls Cardura XL Tablets Due to Degradation Specifications

    Pfizer is recalling 22,461 bottles of Cardura XL 4 mg tablets because the product may not meet specifications for a product degradant.

    Product
    Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2127-2014·2014-08-06

    Small Bone Innovations Recalls AutoFIX Cannulated Compression Screw Systems for IFU Update

    Small Bone Innovations is recalling 506 units of 3.0/4.0mm AutoFIX Cannulated Compression Screw Systems to update the Instructions for Use (IFU).

    Product
    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1486-2014·2014-08-06

    Oxycodone Hydrochloride Oral Solution Recalled for Stability Failure

    Boehringer Ingelheim Roxane Inc is recalling 2,149 vials of Oxycodone Hydrochloride Oral Solution due to out-of-specification preservative levels.

    Product
    OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2129-2014·2014-08-06

    Septodont Recalls Compolite Bond SE Due to Incorrect Packaging

    Septodont is recalling 24 units of Compolite Bond SE dental adhesive because the material was incorrectly packaged. The product was distributed to wholesalers in Pennsylvania and New York.

    Product
    Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-1444-2014·2014-07-30

    X-Gen Recalls Clonidine HCl Injection Due to Labeling Error

    X-Gen Pharmaceuticals is recalling Clonidine HCl Injection vials because the side label incorrectly states the drug strength.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2200-2014·2014-07-30

    Dolci Gelati Recalls YES Green Tea Gelato for Organic Mislabeling

    Dolci Gelati LLC is recalling YES Green Tea Gelato because it was mislabeled as organic. The product was sold exclusively at Yes Organic Market in the MD/DC area.

    Product
    YES Green Tea Gelato
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-1445-2014·2014-07-30

    Sandoz Recalls Orphenadrine Citrate Tablets for Dissolution Failures

    Sandoz Inc. is recalling Orphenadrine Citrate Extended Release Tablets because they failed dissolution specifications during stability testing.

    Product
    ORPHENADRINE CITRATE — ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1452-2014·2014-07-30

    Estee Lauder Recalls DENBLAN Toothpaste Due to Stability Data Issues

    Estee Lauder Inc is recalling 3,791 tubes of DENBLAN Anticavity Fluoride Toothpaste because stability data does not support the product's expiry date.

    Product
    DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2090-2014·2014-07-30

    Zoll Circulation Recalls AutoPulse Accessories Due to Japanese Label Typo

    Zoll Circulation is recalling 161 NiMH batteries and 40 LifeBand packs distributed in Japan due to a typographical error on the Japanese legal label.

    Product
    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable c
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-2201-2014·2014-07-30

    Dolci Gelati Recalls Sea Salt Caramel Gelato for Organic Mislabeling

    Dolci Gelati LLC is recalling YES Sea Salt Caramel Gelato because it was mislabeled as organic. The product was sold exclusively at Yes Organic Market in the MD/DC area.

    Product
    YES Sea Salt Caramel Gelato
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-1440-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling specific lots of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1443-2014·2014-07-23

    Pfizer Recalls Viracept Tablets Due to Incorrect Expiration Date Labeling

    Pfizer is recalling Viracept (nelfinavir mesylate) tablets because some bottles were labeled with an incorrect expiration date of 11/2016 instead of 09/2016.

    Product
    VIRACEPT — VIRACEPT (NELFINAVIR MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2014·2014-07-23

    Teva Recalls Velivet Birth Control Pills Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,265 blister packs of Velivet birth control pills nationwide because impurity test results were out of specification.

    Product
    VELIVET — VELIVET (DESOGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide