The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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34351–34375 of 40325

  • ModerateFDA (Devices)·Z-0425-2015·2014-12-03

    Discus Dental Recalls Relief ACP Oral Care Gel Due to Filling Error

    Discus Dental LLC is recalling Relief ACP Oral Care Gel because some units were filled with hydrogen peroxide instead of phosphate gel, potentially causing increased sensitivity.

    Product
    Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0476-2015·2014-12-03

    Dharma Cavity Varnish Recalled for Missing FDA Clearance

    Dharma Research, Inc. is recalling Dharma Cavity Varnish 15mL because the product was marketed without a cleared 510(k) submission.

    Product
    Dharma Cavity Varnish 15mL
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0477-2015·2014-12-03

    ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing

    ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.

    Product
    7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0418-2015·2014-12-03

    Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides

    Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.

    Product
    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0484-2015·2014-12-03

    CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling

    CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.

    Product
    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2015·2014-12-03

    Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits

    Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2015·2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Replacement Pads

    Zimmer, Inc. is recalling 4,961 Trabecular Metal Tibial Impactor Replacement Pads due to complaints of pad fracture. The recall provides clarifying instructions for assembly and disassembly.

    Product
    Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2015·2014-12-03

    Dharma Cavity Varnish Recalled for Lack of FDA Clearance

    Dharma Research, Inc. is recalling Dharma Cavity Varnish with Fluoride because the product was marketed without a cleared 510(k).

    Product
    Dharma Cavity Varnish with Fluoride
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0431-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Micro Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Micro Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0433-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0437-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Permanent Cautery Spatulas for Housing Degradation

    Intuitive Surgical is recalling 509 units of 8mm Permanent Cautery Spatulas because deviations in reprocessing steps can cause surface degradation of the housing and accelerate mechanical wear.

    Product
    8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0423-2015·2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Pads Due to Fracture Complaints

    Zimmer, Inc. is recalling Trabecular Metal Tibial Impactor Pads to provide clarifying instructions on assembly and disassembly following complaints of pad fracture.

    Product
    Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0430-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Long Tip Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Long Tip Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0436-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Permanent Cautery Hooks Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Permanent Cautery Hooks because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2145-2014·2014-12-03

    Market-Tiers recalls laparoscopic morcellator instructions with missing safety pages

    Market-Tiers Inc. is recalling 100 units of the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System because the Instructions for Use omitted critical safety pages.

    Product
    Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2015·2014-12-03

    Philips BrightView Ultrasound Systems Recalled for Software Issues

    Philips Medical Systems is recalling 85 BrightView ultrasound systems worldwide due to software issues. The voluntary recall was initiated in November 2014.

    Product
    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0438-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Fenestrated Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0448-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Tip-Up Fenestrated Graspers for Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Tip-Up Fenestrated Graspers because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0466-2015·2014-12-03

    Remel Recalls Oxoid Legionella Latex Test Due to False Negative Results

    Remel Inc is recalling Oxoid Legionella Latex Test kits because a reagent may produce false negative results. The recall covers 59 boxes distributed nationwide.

    Product
    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0445-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Small Grasping Retractor for Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of the 8mm Small Grasping Retractor because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0420-2015·2014-12-03

    Siemens Hemoglobin A1c Reagent Cartridges Recalled for Positive Bias

    Siemens is recalling certain lots of Dimension HB1C Flex reagent cartridges because they show a positive bias in hemoglobin A1c measurements.

    Product
    Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0483-2015·2014-12-03

    Beevers Cannulaide Respirator Recalled for Improper Pouch Seal

    Beevers Manufacturing recalled Cannulaide respirators due to improper pouch seals that could affect device shelf life.

    Product
    Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is…
    Category
    Medical Device
    Distribution
    7 states
  • 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
  • LowFDA (Devices)·Z-0469-2015·2014-12-03

    Novadaq LUNA Chest Recalled for Sterile Labeling Error

    Novadaq Technologies is recalling 828 LUNA Chest units because non-sterile drapes were inadvertently mislabeled as sterile.

    Product
    LUNA Chest, Model No. LU4006
    Category
    Medical Device
    Distribution
    Distributed nationwide