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.

7776–7800 of 21595

  • ModerateFDA (Food)·F-0170-2020·2019-11-27

    Basic Reset Recalls Beta Factor Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling 262 bottles of Beta Factor dietary supplement because the product does not conform to Dietary Supplement CGMP regulations.

    Product
    BETA FACTOR DIETARY SUPPLEMENT 60 capsules per plastic bottle, SKU: 100-4F
    Category
    Food
    Distribution
    0 states
  • 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 (Devices)·Z-0507-2020·2019-11-27

    Nucryo PolarCath Balloon Catheters Recalled for Incorrect Sterilization Labeling

    Nucryo Vascular Inc. is recalling 49 PolarCath Balloon Catheters because they were mislabeled as ethylene oxide sterilized instead of E-beam sterilized.

    Product
    The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1239-2020·2019-11-27

    Basic Reset Dino Min Dietary Supplement Recalled for CGMP Non-Compliance

    Basic Reset Inc. is recalling Dino 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
    Dino Min, 60 capsules per plastic bottle, SKU: 100-1C
    Category
    Food
    Distribution
    0 states
  • 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 (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-0180-2020·2019-11-27

    Basic Reset Recalls Body Mass Reset for CGMP Non-Compliance

    Basic Reset Inc. is recalling Body Mass Reset dietary supplements because they do not conform to Dietary Supplement CGMP regulations.

    Product
    Body Mass Reset, 4 fl. oz. plastic bottle, SKU: 100-8C
    Category
    Food
    Distribution
    0 states
  • 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 (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-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 (Drugs)·D-0495-2020·2019-11-27

    Washington Homeopathic Recalls Ferrum Phosphoricum 6X Tablets for CGMP Deviations

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

    Product
    Ferrum 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 64198 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0411-2020·2019-11-27

    Angiodynamics Recalls Mislabelled Starburst Electrosurgical Devices

    Angiodynamics Inc. is recalling 30 Starburst Talon Semi-Flex Electrosurgical Devices that were incorrectly labelled as Starburst MRI Semi-Flex devices, potentially causing procedural delays.

    Product
    Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0516-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Inhalation Vials

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

    Product
    Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0172-2020·2019-11-27

    Basic Reset Recalls Vibrant Energy Drink for CGMP Violations

    Basic Reset Inc. is recalling 1,980 canisters of Vibrant Energy Drink because the products do not conform to Dietary Supplement CGMP regulations.

    Product
    Vibrant ENERGY DRINK 450 g plastic canister 100-4A
    Category
    Food
    Distribution
    0 states
  • 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 (Devices)·Z-0501-2020·2019-11-27

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

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

    Product
    BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - 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 (Drugs)·D-0502-2020·2019-11-27

    Washington Homeopathic Recalls Natrum Sulphuricum 6X Tablets for CGMP Deviations

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

    Product
    Natrum Sulphuricum 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 64193 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2020·2019-11-27

    Neocis Guidance System Fiducial Array Recalled for Measurement Mismatch

    Neocis Inc. is recalling three units of the Neocis Guidance System Fiducial Array because they may mismatch measurement files, resulting in a failed landmark check.

    Product
    Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0496-2020·2019-11-27

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

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

    Product
    Kali 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 64194 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0518-2020·2019-11-27

    Teva Recalls Valganciclovir Hydrochloride Oral Solution Due to Foreign Particles

    Teva Pharmaceuticals is recalling specific lots of Valganciclovir Hydrochloride for Oral Solution because brown or black particles were found during stability testing.

    Product
    VALGANCICLOVIR HYDROCHLORIDE FOR ORAL — VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE)
    Category
    Drug
    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