The Recall Desk

Archive

April 2020 recalls

605 recalls were announced in April 2020.

What the numbers show

Critical
6
Severe
113
High
182
Moderate
294
Low
10

Of the 605 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

301–400 of 605

  • ModerateFDA (Drugs)·D-1149-2020·2020-04-15

    Herbal Doctor Remedies Recalls PC Shrinker Due to Misbranding

    Herbal Doctor Remedies is recalling PC Shrinker because the product was found to be misbranded as an unapproved new drug.

    Product
    PC Shrinker, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1110-2020·2020-04-15

    Herbal Doctor Remedies Recalls Asma Stopper Capsules for Misbranding

    Herbal Doctor Remedies is recalling Asma Stopper capsules because they are misbranded as unapproved new drugs.

    Product
    Asma Stopper, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1645-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1640-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1657-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1132-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes-G Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Herpes-G 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    Herpes-G, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1113-2020·2020-04-15

    Herbal Doctor Remedies Recalls Blood Clot Purger for Misbranding

    Herbal Doctor Remedies is recalling Blood Clot Purger because the product is misbranded as an unapproved new drug.

    Product
    Blood Clot Purger, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1665-2020·2020-04-15

    Biomet Knee Spacer Mold Recalled for Potential Cleaning Deficiencies

    Biomet is recalling StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1670-2020·2020-04-15

    Biomet Recalls Custom StageOne Hip Femoral Reinforcement Due to Cleaning Concerns

    Biomet, Inc. is recalling specific lots of Custom StageOne Hip Femoral Reinforcement due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1115-2020·2020-04-15

    Herbal Doctor Remedies Recalls De-Fibroidin Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling De-Fibroidin 500mg capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    De-Fibroidin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1655-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1161-2020·2020-04-15

    Herbal Doctor Remedies Recalls Skin Moist Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Skin Moist 500mg capsules because they were found to be misbranded as unapproved new drugs.

    Product
    Skin Moist, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1673-2020·2020-04-15

    Beckman Coulter LabPro Data Management System Software Update Recall

    Beckman Coulter is recalling 177 LabPro Data Management Systems because a security update caused some computers to fail to restart, potentially delaying microbiology test results.

    Product
    LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1663-2020·2020-04-15

    Biomet Recalls Knee Spacer Molds Due to Insufficient Cleaning Process

    Biomet, Inc. is recalling 230,001 units of StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning or inadequate process monitoring.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1157-2020·2020-04-15

    Herbal Doctor Remedies Recalls Skin Cleanser Capsules for Misbranding

    Herbal Doctor Remedies is recalling Skin Cleanser capsules because they are misbranded as unapproved new drugs.

    Product
    Skin Cleanser, 500mg Capsules, 90-count bottles2, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1139-2020·2020-04-15

    Herbal Doctor Remedies Recalls Immune-2100 Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Immune-2100 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Immune-2100, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1667-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1123-2020·2020-04-15

    Herbal Doctor Remedies Recalls Fire Off Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Fire Off 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Fire Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1152-2020·2020-04-15

    FDA Recalls Purple Gold Balm for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Purple Gold Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the U.S. and internationally.

    Product
    Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1122-2020·2020-04-15

    Herbal Doctor Remedies Recalls Edema Off for CGMP Deviations

    Herbal Doctor Remedies is recalling Edema Off because the product was found to be misbranded as an unapproved new drug due to CGMP deviations.

    Product
    Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1145-2020·2020-04-15

    Herbal Doctor Remedies Recalls Nasal Ez Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Nasal Ez capsules because they were found to be misbranded as unapproved new drugs.

    Product
    Nasal Ez, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1172-2020·2020-04-15

    Herbal Doctor Remedies Recalls Worm Off Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Worm Off capsules because they are misbranded as unapproved new drugs. The products were sold online in the US and internationally.

    Product
    Worm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1114-2020·2020-04-15

    Herbal Doctor Remedies Recalls Cellulite Off for CGMP Deviations

    Herbal Doctor Remedies is recalling Cellulite Off because the product was found to be misbranded as an unapproved new drug.

    Product
    Cellulite Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1129-2020·2020-04-15

    Herbal Doctor Remedies Recalls Hair Back Ex Due to Misbranding

    Herbal Doctor Remedies is recalling Hair Back Ex capsules because they are misbranded as unapproved new drugs.

    Product
    Hair Back Ex, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1656-2020·2020-04-15

    Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes and inadequate process monitoring.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1126-2020·2020-04-15

    Herbal Doctor Remedies Recalls Fungo Balm for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Fungo Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the U.S. and internationally.

    Product
    Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1141-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lump Shrinker Capsules for Misbranding

    Herbal Doctor Remedies is recalling Lump Shrinker capsules because the products are misbranded as unapproved new drugs.

    Product
    Lump Shrinker, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1154-2020·2020-04-15

    Herbal Doctor Remedies Recalls Reman-6 Capsules Due to CGMP Deviations

    Herbal Doctor Remedies is recalling Reman-6 500mg capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Reman-6, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1173-2020·2020-04-15

    Herbal Doctor Remedies Recalls BioMycin Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling BioMycin 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    BioMycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1166-2020·2020-04-15

    Herbal Doctor Remedies Recalls Thyro-Lo Capsules for Unapproved Drug Status

    Herbal Doctor Remedies is recalling Thyro-Lo 500mg capsules because they are misbranded as unapproved new drugs. The products were sold online in the US and internationally.

    Product
    Thyro-Lo, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1170-2020·2020-04-15

    Vitiligo Off Ointment Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Vitiligo Off Ointment because it is misbranded as an unapproved new drug.

    Product
    Vitiligo Off Ointment, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1128-2020·2020-04-15

    Herbal Doctor Remedies Recalls Fungo Off Capsules for Misbranding

    Herbal Doctor Remedies is recalling Fungo Off 500mg capsules because they were found to be misbranded as unapproved new drugs.

    Product
    Fungo Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1142-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lupus Care for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Lupus Care because the product is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Lupus Care, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1165-2020·2020-04-15

    Herbal Doctor Remedies Recalls Sweat Oil for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Sweat Oil because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Sweat Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1105-2020·2020-04-15

    Herbal Doctor Remedies Recalls Acupuncture Products for Misbranding

    Herbal Doctor Remedies is recalling acupuncture products sold online in the US and internationally because they are misbranded as unapproved new drugs.

    Product
    Acupuncture, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1117-2020·2020-04-15

    Herbal Doctor Remedies Recalls Dermatoxin Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Dermatoxin 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    Dermatoxin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1106-2020·2020-04-15

    Herbal Doctor Remedies Recalls Acne Cystic Capsules for Misbranding

    Herbal Doctor Remedies is recalling Acne Cystic 500 mg capsules because they are misbranded as unapproved new drugs.

    Product
    Acne Cystic, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1134-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes Soap for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Herpes Soap because the product is misbranded as an unapproved new drug. The soap was sold online in the US and internationally.

    Product
    Herpes Soap, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1146-2020·2020-04-15

    Herbal Doctor Remedies Recalls New Life Due to Unapproved New Drug Status

    Herbal Doctor Remedies is recalling New Life because the product is misbranded as an unapproved new drug. The recall covers all lots within expiry sold online in the US and internationally.

    Product
    New Life, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1155-2020·2020-04-15

    Herbal Doctor Remedies Recalls Reman-8 Capsules Due to Unapproved Drug Status

    Herbal Doctor Remedies is recalling Reman-8 capsules because the products are misbranded as unapproved new drugs.

    Product
    Reman-8, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1150-2020·2020-04-15

    Herbal Doctor Remedies Recalls Phlegm Off Capsules Due to Unapproved Status

    Herbal Doctor Remedies is recalling Phlegm Off capsules because the products are misbranded as unapproved new drugs.

    Product
    Phlegm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1108-2020·2020-04-15

    Herbal Doctor Remedies Recalls Age Back Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Age Back 500 mg capsules because they are misbranded as unapproved new drugs.

    Product
    Age Back, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1119-2020·2020-04-15

    Herbal Doctor Remedies Recalls Detoxin Ex Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Detoxin Ex capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Detoxin Ex, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1156-2020·2020-04-15

    Herbal Doctor Remedies Recalls Reman-AP Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Reman-AP 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Reman-AP, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1135-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes V Balm for CGMP Deviations

    Herbal Doctor Remedies is recalling Herpes V Balm because the product was found to be misbranded as an unapproved new drug.

    Product
    Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1649-2020·2020-04-15

    Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1664-2020·2020-04-15

    Biomet Recalls Knee Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling BIOMET StageOne Knee Femoral Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1651-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1661-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1658-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1669-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1691-2020·2020-04-15

    Microbiologics QC Sets Recalled for Potential Mislabeling of Fungal Strains

    Microbiologics Inc is recalling QC sets that may contain Candida utilis instead of the labeled Trichosporon dermatis.

    Product
    Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1169-2020·2020-04-15

    Herbal Doctor Remedies Recalls Unapproved Vigo-XXX Capsules

    Herbal Doctor Remedies is recalling Vigo-XXX 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    Vigo-XXX, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1672-2020·2020-04-15

    Qualigen FastPack SHBG Immunoassay Kit Recalled for Inaccurate Results

    Qualigen Inc is recalling FastPack System Complete Immunoassay Kits for SHBG because they may produce higher than expected results, leading to inaccurate quantitative determinations.

    Product
    The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1690-2020·2020-04-15

    Microbiologics Recalls KWIK-STIK Trichosporon Dermatis Culture Pack

    Microbiologics Inc is recalling KWIK-STIK 2 Pack Trichosporon dermatis cultures because they may contain Candida utilis instead of the labeled organism.

    Product
    KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1662-2020·2020-04-15

    Biomet Recalls Knee Spacer Molds Due to Insufficient Cleaning Process

    Biomet, Inc. is recalling 230,001 units of StageOne Knee Femoral Cement Spacer Molds due to a potentially insufficient cleaning process or inadequate process monitoring.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1685-2020·2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1107-2020·2020-04-15

    Acne Off Recalled for CGMP Deviations and Misbranding as Unapproved New Drug

    Herbal Doctor Remedies is recalling Acne Off because the product was found to be misbranded as an unapproved new drug due to CGMP deviations.

    Product
    Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1120-2020·2020-04-15

    Herbal Doctor Remedies Recalls Detoxin-S Capsules Due to CGMP Deviations

    Herbal Doctor Remedies is recalling Detoxin-S 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Detoxin-S, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1147-2020·2020-04-15

    Herbal Doctor Remedies Recalls Pain Away Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Pain Away 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Pain Away, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1160-2020·2020-04-15

    Herbal Doctor Remedies Recalls Skin Lift Balm for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Skin Lift Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the US and internationally.

    Product
    Skin Lift Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1163-2020·2020-04-15

    Herbal Doctor Remedies Recalls Stomach Cleanser Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Stomach Cleanser capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1125-2020·2020-04-15

    Fungo Balm Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Fungo Balm because the product is misbranded as an unapproved new drug.

    Product
    Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1158-2020·2020-04-15

    Herbal Doctor Remedies Recalls Skin De-Tag for Unapproved Drug Status

    Herbal Doctor Remedies is recalling Skin De-Tag because the product is misbranded as an unapproved new drug.

    Product
    Skin De-Tag, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1148-2020·2020-04-15

    FDA Recalls Pain Stopper Capsules Due to Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Pain Stopper 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    Pain Stopper, 500mg Capsules, 90-count bottle, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1127-2020·2020-04-15

    Fungo Lotion Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Fungo Lotion because it is misbranded as an unapproved new drug.

    Product
    Fungo Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1130-2020·2020-04-15

    Herbal Doctor Remedies Recalls Hair Back Lotion for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Hair Back Lotion because the product is misbranded as an unapproved new drug. The lotion was sold online in the U.S. and internationally.

    Product
    Hair Back Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1124-2020·2020-04-15

    Herbal Doctor Remedies Recalls Flare Off Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Flare Off 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Flare Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1111-2020·2020-04-15

    Herbal Doctor Remedies Recalls Asthma Chest Rub for Misbranding

    Herbal Doctor Remedies is recalling Asthma Chest Rub because the product is misbranded as an unapproved new drug.

    Product
    Asthma Chest Rub, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1164-2020·2020-04-15

    Herbal Doctor Remedies Recalls Sugar Off Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Sugar Off 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Sugar Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1162-2020·2020-04-15

    Herbal Doctor Remedies Recalls Sperm Booster for Misbranding

    Herbal Doctor Remedies is recalling Sperm Booster because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1136-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes V Balm for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Herpes V Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the US and internationally.

    Product
    Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1151-2020·2020-04-15

    Herbal Doctor Remedies Recalls Pimples Off Solution for Misbranding

    Herbal Doctor Remedies is recalling Pimples Off Solution because the product is misbranded as an unapproved new drug.

    Product
    Pimples Off Solution 60 ML, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1652-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1687-2020·2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2020·2020-04-15

    Zimmer Oscillating Saw Blade Recalled for Incorrect Width Labeling

    Synvasive Technology is recalling 266 Zimmer oscillating saw blades because the label indicates a width of 25 mm, but the actual blade width is 19 mm.

    Product
    ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1668-2020·2020-04-15

    Biomet Knee Tibial Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
    Category
    Medical Device
    Distribution
    49 states
  • HighNHTSA·20V214000·2020-04-14

    Commercial Truck Rear Reflective Tape Obstruction Creates Visibility Risk

    Daimler Trucks is recalling certain commercial trucks where the mudflap hanger bracket partially covers rear reflective tape, reducing visibility. Owners should contact DTNA or NHTSA for free inspection and repositioning.

    Product
    FREIGHTLINER — FREIGHTLINER, STERLING, WESTERN STAR COLUMBIA, CLASSIC XL, 122SD, FLD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E022000·2020-04-13

    Takata Driver Air Bag Inflator Recall for Honda and Nissan Vehicles

    Honda and Nissan are recalling vehicles with Takata driver air bag inflators that may explode during deployment, posing a risk of serious injury or death.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·008·2020-04-10

    Jowett Farms Recalls Pork Sausage Products Lacking Import Inspection

    Jowett Farms is recalling approximately 42,587 pounds of raw pork trimmings and processed sausage products that were not presented for import re-inspection into the United States.

    Product
    Jowett Farms Corporation Recalls Pork Products Produced without Benefit of Import Inspection
    Category
    Food
    Distribution
    2 states
  • SevereUSDA FSIS·007-2020·2020-04-10

    Conagra Recalls Frozen Chicken Bowls Due to Possible Rock Contamination

    Conagra Brands is recalling approximately 130,763 pounds of frozen Healthy Choice Chicken Feta & Farro bowls because they may contain small rocks.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands, Inc. Recalls Frozen Not-Ready-to-Eat Chicken Bowl Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V211000·2020-04-10

    Freightliner and Western Star trucks recalled for incorrect weight rating labels

    Daimler Trucks North America is recalling 2020-2021 Freightliner and Western Star commercial trucks with incorrect weight-rating labels. Incorrectly labeled trucks could be overloaded, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR CORONADO, 114SD, 4700, 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E021000·2020-04-10

    Winkelmann CNG Cylinder Label Recall for Inspection Compliance

    Winkelmann Flowform Technology LP is recalling 327-liter compressed natural gas cylinders because label font size and missing designations may prevent inspection, increasing fire risk.

    Product
    EQUIPMENT:OTHER:LABELS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V213000·2020-04-09

    Hyundai Recalls 2020 Nexo and Sonata for Parking Software Defect

    Hyundai is recalling 2020 Nexo and Sonata vehicles because a software defect in the Remote Smart Parking Assist system may allow unintended vehicle movement, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI NEXO, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V207000·2020-04-09

    RAM 2500 and 3500 Trucks Recalled for Bed Step Failure Risk

    Chrysler is recalling 2019-2020 RAM 2500 and 3500 trucks because the accessory bed step may fail during use, increasing injury risk.

    Product
    RAM — RAM 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V209000·2020-04-09

    Forest River Recalls 2021 Starcraft Bus All Star Over Wiring Chafing

    Forest River is recalling 2021 Starcraft Bus All Star transit buses because a wire harness may chafe against the frame, potentially causing engine stalls or loss of braking stability.

    Product
    STARCRAFT BUS — STARCRAFT BUS ALL STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V210000·2020-04-09

    StarCraft Starquest School Bus Recall for Wire Harness Chaffing

    Forest River is recalling 2022 StarCraft Starquest school buses because a wire harness may chafe against the frame, potentially causing engine stalls or loss of braking stability.

    Product
    STARCRAFT BUS — STARCRAFT BUS STARQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E020000·2020-04-09

    Chrysler Recalls Mopar Rear Bed Step Kits for Ram Trucks

    Chrysler is recalling Mopar Rear Bed Step Kits for Ram heavy-duty trucks because the bed step may fail during side loading, increasing injury risk.

    Product
    STRUCTURE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V208000·2020-04-09

    Chrysler Recalls 2019-2020 Ram 1500 and Jeep Compass for Wiper Defect

    Chrysler is recalling 2019-2020 Ram 1500 and Jeep Compass vehicles because windshield wiper arms may loosen, reducing visibility and increasing crash risk.

    Product
    RAM — RAM, JEEP 1500, COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1080-2020·2020-04-08

    Natural Remedies Active Male Formula Recalled for Undeclared Tadalafil

    FDA is recalling Natural Remedies Active Male 500 mg dietary supplements because they contain undeclared Tadalafil, an FDA-approved drug for erectile dysfunction.

    Product
    Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Food)·F-0910-2020·2020-04-08

    Guan's Enoki Mushrooms Recalled Due to Listeria monocytogenes Contamination

    Forest Mushroom Food Inc. is recalling Guan's Enoki Mushrooms after California health officials detected Listeria monocytogenes in retail samples.

    Product
    Guan's Enoki Mushrooms; Net Weight 200 g - 7.05 oz. UPC: 8 59267007013 Product Number:50130 Product of Korea, Keep refrigerated Distributed by Guan's Mushroom Co. Los Angeles, CA Package is clear plastic top with Guan's logo, green bottom with Enoki Mushroom in English
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·20V202000·2020-04-08

    Great Dane Recalls 2020-2021 Everest Vans Due to Axle Nut Clip Defect

    Great Dane is recalling 2020-2021 Everest Refrigerated Vans because improperly installed axle nut retaining clips may cause loose wheels and loss of vehicle control.

    Product
    GREAT DANE — GREAT DANE EVEREST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20107·2020-04-08

    Continuum Recalls Lenox Tea Kettles Due to Burn Hazard

    Continuum is recalling Lenox 2.5 Quart Tea Kettles because they can expel hot water, posing a burn hazard. Consumers should stop using the kettles and contact the company for a refund.

    Product
    Lenox 2.5 Quart Tea Kettles
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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