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.

1551–1575 of 2769

  • LowFDA (Devices)·Z-2804-2016·2016-09-21

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Calibrator Kit 31

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 31, Lot 3155, because an incorrect value on the Assay Data Disks prevents successful calibration of the HbA1c assay.

    Product
    The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2778-2016·2016-09-21

    Alere LDX Optical Check Cassettes Recalled for Incorrect Expiration Date

    Alere San Diego, Inc. is recalling LDX Optical Check Cassettes because the expiration date on the magnetic strip does not match the labeled date.

    Product
    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2100-2016·2016-09-21

    WTI All Natural DV Recalled for Foreign Wood Matter

    WTI, Inc. is recalling 308,140 lbs of All Natural DV because wood pieces were found in the product. The affected lots were distributed in Illinois and Canada.

    Product
    WTI (World Technology Ingredients) DV, All Natural, 35 lbs./15.9 kg, WTI, Inc., 281 MLK Ave., Jefferson, GA 30549.
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-2779-2016·2016-09-21

    Biomerieux Recalls VIDAS NT-pro-BNP Kits Due to Packaging Error

    Biomerieux is recalling 229 VIDAS NT-pro-BNP kits because they contain the incorrect number of control vials.

    Product
    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA techniqu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2719-2016·2016-09-14

    ReliaMed Silver Alginate Dressing Recalled for Missing Instructions

    Advanced Medical Solutions is recalling ReliaMed Silver Alginate dressings because some cartons are missing the required Instructions For Use leaflet.

    Product
    ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1492-2016·2016-09-14

    Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-2740-2016·2016-09-14

    Arrow Arterial Line Catheterization Kits Recalled for Shipping Labeling Error

    Arrow International Inc. is recalling 690 Arterial Line Catheterization Kits due to a shipping carton labeling error. The kits were distributed nationwide to five states.

    Product
    Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1479-2016·2016-09-14

    Stason Recalls Selegiline HCl Tablets Due to Dissolution Failure

    Stason Pharmaceuticals is recalling Selegiline HCl tablets 5mg due to out-of-specification dissolution results for stability samples.

    Product
    Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1476-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1473-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2707-2016·2016-09-07

    Limacorporate SMR Allen Wrench Recalled for Dimensional Non-Conformance

    Limacorporate S.p.A is recalling 76 SMR allen wrenches (5 mm) because they are dimensionally non-conforming and may not function with some T-handles.

    Product
    SMR allen wrench 5 mm, product code 9013.50.210
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1471-2016·2016-08-31

    Actavis Recalls Acetasol HC Otic Solution Due to Impurity Failure

    Actavis Inc is recalling 672 bottles of Acetasol HC otic solution because stability testing showed an out-of-specification related compound at the 12-month time point.

    Product
    Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1472-2016·2016-08-31

    Actavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities

    Actavis Inc. is recalling 2,543 bottles of Hydrocortisone and acetic acid otic solution because stability testing showed out-of-specification results for a related compound.

    Product
    Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1464-2016·2016-08-31

    Stratus Pharmaceuticals Recalls Remeven Cream Due to Crystallization

    Stratus Pharmaceuticals is recalling Remeven Cream because the product has crystallized. The recall covers specific lots of 5.0 oz and 9.0 oz tubes.

    Product
    Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1465-2016·2016-08-31

    Exact-Rx Recalls Urea Cream Due to Crystallization

    Exact-Rx Inc. is recalling specific lots of Urea (50% Urea in a Cream Base) because crystals formed in the product.

    Product
    Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2601-2016·2016-08-31

    Siemens RAPIDPoint 500 Software Upgrade Kit Recalled for Uncleared Mode

    Siemens is recalling 76 RAPIDPoint 500 software upgrade kits because some include a dialysate mode not cleared for shipment in the United States.

    Product
    Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1469-2016·2016-08-31

    Akorn Recalls Desoximetasone Gel Due to Impurity Specification Failure

    Akorn, Inc. is recalling Desoximetasone Gel USP, 0.05%, because the product failed impurity specifications at the 9-month stability time point.

    Product
    Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2538-2016·2016-08-24

    Telefax Medical Recalls Weck EFx Fascial Closure System for Labeling Error

    Teleflex Medical is recalling 45 units of the Weck EFx Classic Fascial Closure System because incorrect expiration dates were printed on the labels.

    Product
    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2523-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants

    Biomet 3i is recalling certain Gingihue Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2471-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implant devices because pouches may not have been sealed during packing.

    Product
    Implant EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2493-2016·2016-08-24

    Biomet 3i Recalls Preformance Temporary Cylinder Dental Implants

    Biomet 3i, LLC is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Preformance Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2453-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Pick-Up Coping (Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2430-2016·2016-08-24

    Biomet 3i Recalls Locator Light Retention Dental Implant Components

    Biomet 3i is recalling Locator Light Retention Replacement Males because pouches may not have been sealed during packing.

    Product
    Locator Light Retention Replacement Males 4pk Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2434-2016·2016-08-24

    Biomet 3i Recalls Pick-Up Impression Coping Dental Implants

    Biomet 3i is recalling Pick-Up Impression Coping dental implants because pouches may not have been sealed during packing.

    Product
    Pick-Up Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide