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.

2126–2150 of 2769

  • LowFDA (Devices)·Z-0012-2015·2014-10-15

    Richard-Allan Scientific Recalls Protocol 10% NBF Tissue Fixative

    Richard-Allan Scientific is recalling 175 cases of Protocol 10% NBF tissue fixative because the concentration may be outside specifications.

    Product
    Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0014-2015·2014-10-15

    Bracco Recalls E-Z-GAS Antacid Due to Subpotent Drug Levels

    Bracco Diagnostic Inc is recalling E-Z-GAS antacid packets because routine stability testing found the drug to be subpotent.

    Product
    E-Z-GAS — E-Z-GAS (ANTACID/ANTIFLATULENT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2718-2014·2014-10-08

    St. Jude Medical Percutaneous Trial Lead Kit Manual Recall

    St. Jude Medical is recalling 2 units of Percutaneous Trial Lead Kit Model 3046 because the included manual contained information for devices not approved in the US.

    Product
    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Food)·F-2489-2014·2014-10-01

    Turkana Food Recalls Turkish Delight Containing Unapproved Color

    Turkana Food Inc. is recalling Tunas Turkish Delight Rose Flavored because it contains Ponceau 4R, a color additive not approved for use in the United States.

    Product
    Tunas Turkish Delight Rose Flavored, Net Wt. 14.11 oz., US Importer and Distributor: Turkana Food, Inc., Exporter: Tunas Food Industry, UPC 86925940080
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-2650-2014·2014-09-24

    Stago IVD Liquid Anti-Xa Recalled for Barcode Misreading

    Diagnostica Stago is recalling 514 Liquid Anti-Xa kits due to customer complaints about barcode misreading on analyzers.

    Product
    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2644-2014·2014-09-24

    BioFire Defense Recalls JBAIDS Instrument System Software Version 3.5.0.72

    BioFire Defense is recalling JBAIDS Instrument System Software version 3.5.0.72 because the wrong version may have been installed on the devices.

    Product
    JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The sof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1570-2014·2014-09-24

    Apotex Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity

    Apotex Corp. is recalling Candesartan Cilexetil and Hydrochlorothiazide Tablets because a specific degradant exceeded safety specifications.

    Product
    Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2421-2014·2014-09-17

    Grace Classic Coconut Milk Recalled for Label Misprint

    Grace Foods (USA) Inc is recalling Grace Classic Coconut Milk cans due to a label misprint that incorrectly states no gums, thickeners, or stabilizers were added.

    Product
    Grace Classic Coconut Milk Net 13.5 FL OZ (US) (400 mL) PRODUCT OF THAILAND Packed for: GraceKennedy Limited, 73 Harbour Street Kingston, Jamaica, W.I.
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-1569-2014·2014-09-17

    Chirothin Dietary Supplement Recalled for Unapproved Human Chorionic Gonadotropin

    ChiroNutraceutical LLC is recalling Chirothin dietary supplement bottles because the product contains unapproved human chorionic gonadotropin (hCG) and was marketed without an approved NDA or ANDA.

    Product
    CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2594-2014·2014-09-17

    Biomet 3i Healing Abutments Recalled for Incorrect Label Color Coding

    Biomet 3i is recalling 6 units of Bellatek Encode Healing Abutments because the labels have incorrect color coding, though the identifiers are correct.

    Product
    BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2568-2014·2014-09-10

    Datascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error

    Datascope Corporation is recalling Linear 7.5 FR 40cc Intra-Aortic Balloon Catheters due to a duplicate serial number label detected during label reconciliation.

    Product
    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2559-2014·2014-09-03

    Nanosphere Recalls Verigene CYP2C19 Nucleic Acid Test Kits

    Nanosphere is recalling 78 Verigene CYP2C19 Nucleic Acid Test kits due to an unacceptable increase in initial no-call rates.

    Product
    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-2538-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • LowFDA (Drugs)·D-1484-2014·2014-09-03

    Novel Laboratories Recalls Famotidine Oral Suspension Due to Impurity Failure

    Novel Laboratories is recalling 25,776 containers of Famotidine Oral Suspension because the product failed an impurity specification. The recall is classified as FDA Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1557-2014·2014-09-03

    Mylan Recalls Diltiazem HCl Extended Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended Release Capsules because routine stability testing found high levels of a related compound.

    Product
    Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1544-2014·2014-08-27

    Triveen PRx RNF Capsules Recalled for Incorrect Vitamin B12 Labeling

    Trigen Laboratories is recalling Triveen PRx RNF Capsules because the label lists Vitamin B12, which is not in the formulation.

    Product
    Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1539-2014·2014-08-27

    Mylan Recalls Tolterodine Tartrate Tablets Due to Impurity Failures

    Mylan Pharmaceuticals is recalling 9,225 bottles of Tolterodine Tartrate Tablets, 1 mg, because the product failed impurity specifications for lactol and total impurities.

    Product
    Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2264-2014·2014-08-27

    Hyperion Medical Recalls HyperBlue 1530 Laser Brochures for Misleading Claims

    Hyperion Medical is recalling brochures and website information for the HyperBlue 1530 laser because they promoted features not cleared by the FDA.

    Product
    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-2178-2014·2014-08-20

    Agfa Healthcare Recalls Radiographic Film Due to Fogged Sheets

    Agfa Healthcare is recalling specific lots of radiographic film because some sheets are fogged, which may affect image quality.

    Product
    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2176-2014·2014-08-20

    Agfa Digital Radiography X-Ray System Recalled for Mislabeled Output Power

    AGFA Healthcare Corp. is recalling one Agfa Digital Radiography X-Ray System DX-D 100 unit in West Virginia because it was mislabeled with a factory label showing 32 KW output power.

    Product
    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1537-2014·2014-08-20

    Pfizer Recalls Depo-Medrol Vials Due to pH Specification Failure

    Pfizer is recalling 93,800 vials of Depo-Medrol (methylprednisolone acetate) because a stability test showed a pH level below the registered specification.

    Product
    DEPO-MEDROL — DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2304-2014·2014-08-20

    Allegro Original Marinade Recalled for Elevated Yeast Levels

    Allegro Fine Foods Inc is recalling Allegro Original Marinade due to elevated yeast levels that may cause premature spoilage.

    Product
    Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7
    Category
    Food
    Distribution
    12 states
  • LowFDA (Devices)·Z-2135-2014·2014-08-20

    Enhancement Medical Recalls Injectable Gel Due to Production Process Change

    Enhancement Medical is recalling 17,875 units of EXP-150 Injectable Gel because a production change altered the final gel weight. The recall covers all lots distributed in the US and Canada.

    Product
    Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2233-2014·2014-08-20

    BD Multi Check CD4 Low Control Recalled for Incorrect Date Labeling

    BD Biosciences is recalling 85 units of BD Multi Check CD4 Low Control due to an incorrect distribution date on the outer box label.

    Product
    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
    Category
    Medical Device
    Distribution
    9 states