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.

17226–17250 of 21645

  • ModerateFDA (Devices)·Z-0449-2015·2014-12-03

    Remel TB Potassium Permanganate Stain Recalled for Performance Issues

    Remel Inc is recalling TB Potassium Permanganate stain due to potential cloudiness or discoloration that may affect mycobacterial diagnosis.

    Product
    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0444-2015·2014-12-03

    Intuitive Surgical Recalls 8mm MEGA SUTURECUT ND Instruments

    Intuitive Surgical is recalling 509 units of 8mm MEGA SUTURECUT ND instruments due to potential surface degradation and accelerated mechanical wear.

    Product
    8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1580-2014·2014-11-26

    Medtronic Recalls Sterile Drill Bits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.

    Product
    BIT 9733516 2.9mm DRILL STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0527-2015·2014-11-26

    Formulations For Life Recalls Vision Assure Extra Strength Vision Formula

    Formulations For Life is recalling Vision Assure Extra Strength Vision Formula dietary supplements due to lack of Good Manufacturing Practices and misbranding.

    Product
    FORMULATIONS FOR LIFE Vision Assure Extra Strength Vision Formula DIETARY SUPPLEMENT, 1) 60 VEGETARIAN CAPSULES, 2) 120 VEGETARIAN CAPSULES. Distributed by: Formulations for Life Hauppauge, New York 11788 USA.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1599-2014·2014-11-26

    Medtronic Recalls AxiEM Tumor Resonance Packs Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RES. PACK 9733553 AxiEM S.M.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2014·2014-11-26

    Medtronic Recalls Sterile O-Arm Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile O-Arm devices because returned units may not have been properly inspected for damage that could compromise sterility.

    Product
    MOUSE 9732721 STERILE O-ARM 10PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0249-2015·2014-11-26

    Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Specifications

    Prometheus Laboratories is recalling Mercaptopurine Tablets 50mg because the product failed dissolution specifications during stability testing.

    Product
    Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0214-2015·2014-11-26

    Siemens ADVIA Centaur Cleaning Solution Recalled for Stability Concerns

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cleaning Solution because its stability is not assured. The product is used in in vitro diagnostic systems.

    Product
    ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0525-2015·2014-11-26

    Formulations For Life Recalls GENE STRENGTH Supplements for Misbranding

    Formulations For Life is recalling GENE STRENGTH Purple Longevity dietary supplements due to lack of Good Manufacturing Practices and misbranding.

    Product
    Anti-Aging Naturals GENE STRENGTH Purple Longevity Dietary Supplement, 60 Vegetarian Capsules. Manufactured for Anti-Aging Naturals Venetia, Pennsylvania 15367 USA.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0217-2015·2014-11-26

    Edwards Lifesciences Recalls Vent Catheters Due to Stylet Coating Disruption

    Edwards Lifesciences is recalling Vent Catheters because the white plastic coating on the stylet may disrupt. The action covers 157,305 units distributed worldwide.

    Product
    Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct…
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-1589-2014·2014-11-26

    Medtronic Recalls AxIEM CR Tumor Resection Devices Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 AxIEM CR tumor resection devices because returned units may not have been properly inspected for damage that could compromise sterility.

    Product
    PACK 9731975 TUMOR RESECTION AXIEM CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1592-2014·2014-11-26

    Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    PIN, 9733235, 100MM, STERILE, PERC REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2014·2014-11-26

    Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.

    Product
    TRAJ GUIDE KIT, 9733066, BIOPSY, INT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2014·2014-11-26

    Medtronic Recalls Thoracic Tactile Probes Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 thoracic tactile probe kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    KIT, 9731427, THORACIC TACTILE PROBES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2015·2014-11-26

    Nidek MC-500 Laser Photocoagulator Recalled for Unreported Engineering Change

    Nidek Inc is recalling five MC-500 Multicolor Laser Photocoagulators because an engineering change order regarding a memory function problem was not reported as required.

    Product
    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1584-2014·2014-11-26

    Medtronic Recalls ENT Navigation Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    ENT PRGM 9734636 ADD FUSION NAV AxiEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2014·2014-11-26

    Medtronic Recalls Tumor Resection Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RESECTION KIT 9733608 SKULL MOUNT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0526-2015·2014-11-26

    Formulations For Life Recalls Resevera Action Dietary Supplements for Misbranding

    Formulations For Life is recalling Resevera Action High Potency Longevity Complex dietary supplements due to lack of Good Manufacturing Practices and misbranding.

    Product
    FORMULATIONS FOR LIFE Resevera Action High Potency Longevity Complex DIETARY SUPPLEMENT, 60 VEGETARIAN CAPSULES. Distributed by: Formulations for LIfe Hauppauge, New York 11788 USA.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1597-2014·2014-11-26

    Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.

    Product
    TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0245-2015·2014-11-19

    Fougera Recalls Fluocinonide Gel Due to Residual Solvent Concerns

    Fougera Pharmaceuticals is recalling specific lots of Fluocinonide Gel USP, 0.05% because they may not meet USP requirements for residual solvents.

    Product
    FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0248-2015·2014-11-19

    Assured Naproxen Sodium Tablets Recalled Due to Mispackaging Error

    Contract Packaging Resources Inc. is recalling Assured Naproxen Sodium Tablets because correct labeled bottles of Assured Ibuprofen softgels were mistakenly packaged into Naproxen cartons.

    Product
    Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0191-2015·2014-11-19

    Bard PerFix Light Plug Recalled for Labeling Mismatch

    Davol, Inc. is recalling 78 units of Bard PerFix Light Plug because the patient record label did not match the actual product in the packaging.

    Product
    Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0211-2015·2014-11-19

    Maquet Cardiohelp-I System Recalled for Potential Software Display Error

    Maquet Cardiovascular is recalling 331 Cardiohelp-I Systems due to a software issue that may display an erroneous 'Battery Needs Service' message after startup.

    Product
    Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours).…
    Category
    Medical Device
    Distribution
    Distributed nationwide