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.

2601–2625 of 2769

  • LowFDA (Devices)·Z-0680-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 5 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-128-2013·2013-01-23

    Teva Recalls Cabergoline Tablets Due to Impurity Specification Failure

    Teva Pharmaceuticals is recalling 13,232 bottles of Cabergoline 0.5 mg tablets because the product may not meet impurity specifications over its shelf life.

    Product
    CABERGOLINE — CABERGOLINE (CABERGOLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0682-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate due to potential discoloration. The product is used for hemodialysis treatment.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0684-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 2,711 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-127-2013·2013-01-23

    Upsher Smith Recalls Divalproex Sodium Tablets Due to Labeling Error

    Upsher Smith is recalling 11,316 bottles of Divalproex Sodium Delayed-Release Tablets because some labels are missing the color-coded strength indicator.

    Product
    Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0676-2013·2013-01-23

    Fresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0681-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0861-2013·2013-01-16

    Meijer Redskin Peanuts Recalled for Incorrect Sodium Labeling

    Meijer Distribution is recalling 16oz Redskin Peanuts because sodium content was not correctly stated on the label. No illnesses have been reported.

    Product
    Markets of Meijer 16oz Redskin Peanuts
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-0639-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling specific lots of Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0646-2013·2013-01-16

    Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues

    Siemens Healthcare Diagnostics is recalling specific lots of Coat-A-Consta IRMA TSH calibrators due to confirmed under-recovery of dose values.

    Product
    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0665-2013·2013-01-16

    Siemens Emit Tox Serum Calibrators Recalled for Incorrect Expiration Date

    Siemens Healthcare Diagnostics is recalling 1,998 cartons of Emit Tox Serum Calibrators because an incorrect expiration date was assigned to Lot D1.

    Product
    Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0638-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0635-2013·2013-01-16

    Siemens Chek-Stix Urine Control Strips Recalled for Temperature Sensitivity

    Siemens Healthcare Diagnostics is recalling Chek-Stix Positive and Negative Control Strips for Urine Chemistry because the leukocyte result may become inaccurate if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0641-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Failure

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0619-2013·2013-01-09

    HemoCue Urine Analyzer Recall for Missing Documentation

    HemoCue AB is recalling 48 urine analyzers because they were shipped with the wrong Quick Reference Guide and a missing warranty statement.

    Product
    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-0617-2013·2013-01-09

    St. Jude Medical Recalls Fast-Cath Transseptal Guiding Introducers Due to Packaging Error

    St. Jude Medical is recalling 26 units of Fast-Cath Transseptal Guiding Introducers because they were packaged with a 180-degree curve instead of the labeled 90-degree curve.

    Product
    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-0608-2013·2013-01-02

    Radiometer Qualicheck 1+ Quality Control Solution Recalled for Barcode Error

    Radiometer America Inc is recalling Qualicheck 1+ quality control solution due to a barcode error that incorrectly enters a pH control range into blood gas analyzers.

    Product
    Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Drugs)·D-097-2013·2012-12-26

    Genentech Recalls CellCept Capsules Due to Short Fill Issues

    Genentech is recalling 1,128 bottles of CellCept (mycophenolate mofetil) 250 mg capsules because some bottles contained fewer than 120 capsules as labeled.

    Product
    CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-098-2013·2012-12-26

    Johnson & Johnson Recalls Clean & Clear Foaming Wash for High Salicylic Acid

    Johnson & Johnson is recalling Clean & Clear Advantage 3-in-1 Foaming Wash because it contains superpotent levels of salicylic acid.

    Product
    Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0829-2013·2012-12-26

    Garden Fresh Gourmet Recalls Salted Tortilla Chips for Quality Standards

    Garden Fresh Salsa, Inc. is recalling specific lots of Garden Fresh Gourmet Salted Tortilla Chips because the ingredients did not meet quality standards.

    Product
    Garden Fresh Gourmet Kettle Style Original Salted Tortilla Chips 14oz (397 g) bags
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-095-2013·2012-12-26

    Bracco Recalls Choletec Kits Due to Particulate Matter

    Bracco Diagnostic Inc is recalling Choletec kits because they may contain particulate matter, including potential charcoal particulates.

    Product
    CHOLETEC — CHOLETEC (MEBROFENIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-094-2013·2012-12-26

    Watson Recalls Caziant Tablets Due to Out-of-Specification Impurities

    Watson Laboratories is recalling Caziant tablets because out-of-specification results were obtained for a known impurity.

    Product
    Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Wa
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0482-2013·2012-12-19

    Hospira Plum A+ Infusion Pumps Recalled for Reversed Volume Control Knob

    Hospira is recalling Plum A+ Hyperbaric Infusion Pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.

    Product
    Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-program
    Category
    Medical Device
    Distribution
    Distributed nationwide