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.

1376–1400 of 2769

  • LowFDA (Devices)·Z-1223-2017·2017-03-01

    Applied Medical Technology Recalls Nasal Tube Retaining Systems Due to Expired Dates

    Applied Medical Technology is recalling 110 units of the AMT Bridle Nasal Tube Retaining System because expired expiration dates are listed on the pouches.

    Product
    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-1237-2017·2017-03-01

    Hidrex USA DVP1000 Recalled Due to Documentation Requirements

    Hidrex GmbH is recalling 180 units of the Hidrex USA DVP1000 device because it was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Hidrex USA DVP1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1238-2017·2017-03-01

    Hidrex Recalls Daavlin Aquex Devices Due to Documentation Requirements

    Hidrex GmbH is recalling 250 Daavlin Aquex (DAAV1000) devices nationwide because the device was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Daavlin Aquex (DAAV1000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1236-2017·2017-03-01

    Hidrex USA DP450 Medical Device Recalled for Documentation Requirements

    Hidrex GmbH is recalling 64 units of the Hidrex USA DP450 device because it was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Hidrex USA DP450
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1224-2017·2017-03-01

    Applied Medical Technology Recalls Expired Feeding Sets

    Applied Medical Technology is recalling 110 units of AMT 12-inch Right Angle Feeding Sets with Y-Ports due to expired expiration dates listed on the pouches.

    Product
    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Drugs)·D-0477-2017·2017-02-22

    Taclonex Topical Suspension Recalled for Outdated Package Insert

    LEO Pharma Inc. is recalling Taclonex topical suspension because it was packaged with an out-of-date package insert.

    Product
    TACLONEX — TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1216-2017·2017-02-22

    Siemens Enzyme 2 Calibrator Recalled for Positive Result Shifts

    Siemens Healthcare Diagnostics is recalling Enzyme 2 Calibrators because they may cause patient and QC results to shift up to 10% when used with the Dimension Vista System.

    Product
    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-1484-2017·2017-02-22

    NOW Foods Recalls Multi-Food 1 Tablets Due to Labeling Error

    NOW Foods is recalling Multi-Food 1 Tablets because the label incorrectly states the molybdenum content is 75 mg instead of 75 mcg.

    Product
    NOW¿ Multi-Food 1 Tablets, One Tablet Daily, 90 tablets, A Dietary Supplement
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1146-2017·2017-02-15

    Thayer MiniSpacer MDI Adapter Recalled for Incorrect Labeling

    Thayer Medical Corporation is recalling 2,550 MiniSpacer MDI adapters because the insert and case labels incorrectly state the connection size.

    Product
    Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0470-2017·2017-02-15

    Aurobindo Recalls Discolored Pantoprazole Sodium Injection Vials

    Aurobindo Pharma USA Inc is recalling 29,800 vials of Pantoprazole Sodium for Injection due to discoloration. The affected vials contain powder with a yellowish-brownish appearance.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1145-2017·2017-02-15

    FDA Recalls Hotline Blood and Fluid Warmers for Incorrect Language Labeling

    Smiths Medical ASD, Inc. is recalling 33 Hotline Blood and Fluid Warmers distributed to Finland because they included Greek and Danish labeling instead of the required Finnish labeling.

    Product
    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditio
    Category
    Medical Device
    Distribution
    0 states
  • LowUSDA FSIS·013-2017·2017-02-15

    Century Packing Recalls Chicken Sausage Products Due to Undeclared MSG

    Century Packing Corp. is recalling approximately 999,419 pounds of chicken sausage products because they contain undeclared monosodium glutamate (MSG).

    Product
    Century Packing Corp. — Century Packing Corp. Recalls Chicken Sausage Products Due To Misbranding
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0471-2017·2017-02-15

    Apotex Recalls Aripiprazole Tablets Due to Potential Potency Issues

    Apotex Inc. is recalling 67,946 bottles of 2 mg Aripiprazole tablets because the product may not meet specifications throughout its shelf life.

    Product
    Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0454-2017·2017-02-08

    Ecolab Recalls Subpotent Chlorhexidine Gluconate Foam Solution

    Ecolab is recalling 427 bottles of Endure 400 Scrub-Stat foam solution because the product was found to be subpotent.

    Product
    Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 5510
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0448-2017·2017-02-01

    Roxane Recalls Azelastine Nasal Spray Due to Defective Delivery System

    Roxane Laboratories is recalling 74,108 bottles of Azelastine Hydrochloride Nasal Spray because the delivery system failed droplet size testing.

    Product
    Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1105-2017·2017-02-01

    Smiths Medical Recalls NORMFlow H-1100 Irrigation Fluid Warmer for Labeling Errors

    Smiths Medical is recalling one NORMFlow H-1100 Irrigation Fluid Warmer in Sweden due to incorrect Spanish labels instead of English.

    Product
    NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1102-2017·2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1059-2017·2017-02-01

    GE OEC 9800 Surgical Table Field Action for Documentation Updates

    GE Healthcare is updating user documentation for OEC 9800 surgical tables to clarify maintenance and component replacement schedules.

    Product
    OEC 9800. MDL Numbers: D222250, D141598
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1101-2017·2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1075-2017·2017-02-01

    Pentax Rigid Laryngostroboscopes Field Correction for Instructions for Use

    Pentax of America is revising the Instructions for Use for Rigid Laryngostroboscopes Models 9106 and 9108.

    Product
    Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0439-2017·2017-02-01

    Actavis Recalls Albuterol Sulfate Inhalation Solution Due to Impurities

    Actavis Inc is recalling specific lots of Albuterol Sulfate Inhalation Solution because the product failed impurity specifications for a known degradant.

    Product
    Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1060-2017·2017-02-01

    GE OEC 9900 Elite Surgical Carts Recalled for Documentation Updates

    GE Healthcare is updating user documentation for OEC 9900 Elite surgical carts to clarify maintenance and component replacement frequencies.

    Product
    OEC 9900 Elite. MDL Numbers: D148942, D155043
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0438-2017·2017-02-01

    Qualitest Recalls Dexamethasone Elixir Due to Failed Impurity Specifications

    Vintage Pharmaceuticals is recalling 2,568 bottles of Dexamethasone Elixir because the product failed impurity and degradation specifications.

    Product
    DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
    Category
    Drug
    Distribution
    Distributed nationwide