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.

551–575 of 2766

  • LowFDA (Devices)·Z-1441-2020·2020-03-11

    Advanced Bionics Recalls SoundWave Professional Suite Software 3.2

    Advanced Bionics is recalling SoundWave Professional Suite Software 3.2 because the installation process fails when using the supplied USB drive, though current software versions remain functional.

    Product
    SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0964-2020·2020-03-11

    Axia Pharmaceutical Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Magnesium Chloride Injection because the company cannot assure the product's sterility.

    Product
    Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0859-2020·2020-03-04

    Akorn Recalls Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown particulate matter inside the tubes.

    Product
    Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0781-2020·2020-03-04

    Nature's Sunshine NutriSmart Soy Powder Recalled for Unapproved Herbicide

    Pro-Form Manufacturing LLC is recalling Nature's Sunshine NutriSmart soy protein powder because the flax seed ingredient contains an unapproved herbicide.

    Product
    Nature's Sunshine NutriSmart Mezcla en polvo a base de proteina de soya enriquecida con vitaminas y minerals; Vainilla Plastic HDPE jar Contenido Neto 510 g UPC: 0 80030910217 Product number: 6116-GE3091 Elaborado por: Nature's Sunshine Products Inc. 1655 North Main Sp
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0856-2020·2020-03-04

    Golden State Medical Supply Recalls Tramadol Tablets Due to Labeling Error

    Golden State Medical Supply is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.

    Product
    TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1390-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake Components

    Maquet Cardiovascular is recalling four Getinge 46-Series Washer Disinfector units because they lack necessary water intake components, preventing proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1354-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 905 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1063-2020·2020-03-04

    Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures

    Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.

    Product
    Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hun
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1391-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake

    Maquet Cardiovascular is recalling 7 Getinge 46-Series Washer Disinfector units because they lack the necessary water intake components for proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1389-2020·2020-03-04

    LivaNova SMART PERFUSION PACK INSPIRE 8S Recalled for Incorrect Cuvette Packaging

    LivaNova USA Inc. is recalling 27 SMART PERFUSION PACK INSPIRE 8S units because they were packaged with the incorrect cuvette component.

    Product
    LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0860-2020·2020-03-04

    Akorn Recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

    Akorn, Inc. is recalling specific tubes of Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper.

    Product
    Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1348-2020·2020-03-04

    Theralase TLC-2000 Laser Power Pack Recalled for Battery Testing Deficiency

    Theralase Inc. is recalling 202 TLC-2000 Therapeutic Medical Laser System Power Packs because the internal battery pack was not tested to IEC-60601-1-2 standards.

    Product
    TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1353-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 660 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0861-2020·2020-03-04

    CVS Health Sodium Chloride Ophthalmic Ointment Recalled for Particulate Matter

    Akorn, Inc. is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper inside the tubes.

    Product
    CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1259-2020·2020-02-26

    Advanced Bionics Cochlear Implant Electrode Recalled for Documentation Error

    Advanced Bionics is recalling four HiResolution Bionic Ear System electrodes in Japan because three materials were omitted from the approved bio-compatibility list.

    Product
    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1239-2020·2020-02-26

    Arrow FlexTip Plus Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 1,150 units of FlexTip Plus Combined Spinal Epidural Catheterization Kits because the product lidstock contains the incorrect expiration date.

    Product
    Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0844-2020·2020-02-26

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failure

    The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-Release Capsules, 28mg, due to failed dissolution specifications observed during stability studies.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1241-2020·2020-02-26

    Arrow StimuCath Continuous Nerve Block Kit Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 155 units of the StimuCath Continuous Nerve Block Kit because the product lidstock contains an incorrect expiration date.

    Product
    Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0851-2020·2020-02-26

    Teva Recalls Tramadol Tablets Due to Incorrect Package Insert Labeling

    Teva Pharmaceuticals is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.

    Product
    Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1326-2020·2020-02-26

    Theralase Inc. Recalls TLC-2000 Therapeutic Medical Laser Systems

    Theralase Inc. is recalling 76 TLC-2000 laser systems because they were shipped with an incorrect power supply model.

    Product
    TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1244-2020·2020-02-26

    Arrow Epidural Needle Component Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 1,839 units of Arrow Epidural Needle Component AN-05505 because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL NEEDLE COMPONENT AN-05505
    Category
    Medical Device
    Distribution
    Distributed nationwide