The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

7801–7825 of 21595

  • ModerateFDA (Drugs)·D-0510-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Vials Due to Processing Controls

    Conversio Health is recalling Albuterol 2.5mg / Ipratropium 0.75mg vials nationwide due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Inhalation Vials for Processing Defects

    Conversio Health is recalling Albuterol, Ipratropium, and Budesonide inhalation vials nationwide due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0412-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is recalling Liquid Cardiac Controls (CQ5051) to remove N-proBNP claims due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Number CQ5051
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0503-2020·2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Non-Filled Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2020·2019-11-27

    Angiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect

    Angiodynamics Inc. is recalling 582 XCELA implantable port kits because snap lock connectors may not meet specifications, preventing catheter insertion.

    Product
    XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0182-2020·2019-11-27

    Basic Reset Recalls Q-min Dietary Supplement for CGMP Non-Compliance

    Basic Reset Inc. is recalling Q-min dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    Q-min, 50 capsules per plastic bottle, SKU: 100-9B
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0176-2020·2019-11-27

    Basic Reset Recalls Mello-Tonin Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling Mello-Tonin dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    Mello-Tonin 2 fl. oz. glass bottle, SKU: 100-5C
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0499-2020·2019-11-27

    Washington Homeopathic Products Recalls Magnesia Phosphorica 6X Tablets

    Washington Homeopathic Products is recalling Magnesia Phosphorica 6X tablets because they were not manufactured under current good manufacturing practices.

    Product
    Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64197 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2020·2019-11-27

    Washington Homeopathic Recalls Natrum Muriaticum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Natrum Muriaticum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64191 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0502-2020·2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Titanium Non-Filled Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Titanium Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0219-2020·2019-11-27

    Temple Turmeric Recalls Matcha Shots Due to High Yeast Levels

    Temple Turmeric Inc. is voluntarily recalling Temple Pure Prana Matcha+Shot bottles due to high levels of yeast. The recall affects 18,732 units distributed to several states.

    Product
    TEMPLE PURE PRANA MATCHA+SHOT; 3 FL OZ (89mL); VITALITY SUPERBOOST; COLD PRESSURED; PERISHABLE KEEP REFRIGERATED; plastic bottles in 12 pack or 24 pack; UPC 8-54351-00547-0
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0506-2020·2019-11-27

    Cook Inc. Recalls Pneumothorax Trays Due to Sterility Compromise Risk

    Cook Inc. is recalling 41 units of Pneumothorax Trays because a perforation line may be positioned over the sterile area, potentially compromising device sterility.

    Product
    Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0414-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is recalling Liquid Cardiac Controls (CQ5053) to remove N-proBNP claims due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0504-2020·2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters

    Angiodynamics Inc. is recalling BIOFLO 8F catheters because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is removing N-proBNP claims from Liquid Cardiac Controls due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Number CQ5052.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0497-2020·2019-11-27

    Washington Homeopathic Products Recalls Kali Phosphoricum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 417 bottles of Kali Phosphoricum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64195 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0179-2020·2019-11-27

    Basic Reset Recalls AquaLyte Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling AquaLyte dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    AquaLyte, 30g pkg./foil pouch, SKU: 1023
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0416-2020·2019-11-27

    Guardia Access Embryo Transfer Catheter Recall Due to Bent Tips

    The FDA is recalling the Guardia Access Embryo Transfer Catheter because bent tips can make insertion difficult, potentially requiring repeat procedures. No injuries have been reported, so the recall is classified as moderate severity.

    Product
    Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0509-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Inhalation Vials

    Conversio Health is recalling Albuterol and Ipratropium inhalation vials nationwide due to a lack of processing controls.

    Product
    Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0417-2020·2019-11-27

    Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System Recall for Warning Updates

    Cincinnati Sub-Zero is recalling 3,932 Blanketrol III Hyper-Hypothermia Systems to add warnings about tissue damage from extended high temperatures and clarify automatic mode usage.

    Product
    Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2020·2019-11-27

    Washington Homeopathic Recalls Calcarea Fluorica 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 489 bottles of Calcarea Fluorica 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64188 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2020·2019-11-27

    Conversio Health Recalls Albuterol and Budesonide Vials Due to Processing Controls

    Conversio Health is recalling Albuterol 2.5mg / Budesonide 0.5mg inhalation vials nationwide due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide