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.

8126–8150 of 21595

  • ModerateFDA (Devices)·Z-2415-2019·2019-09-04

    Stryker Recalls Endotrac ECTR Hook Blades Due to Seal Integrity Concerns

    Stryker GmbH is recalling 1,959 Endotrac ECTR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2019·2019-09-04

    Stryker Endotrac Push Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 251 Endotrac EPF/EGR Push Blades because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2019·2019-09-04

    Ad-Tech Medical Recalls Depth Electrodes Due to Incorrect MR Safety Labeling

    Ad-Tech Medical Instrument Corporation is recalling depth electrodes because supplemental information incorrectly stated they were approved for use in the MR environment.

    Product
    Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2412-2019·2019-09-04

    Stryker Recalls Endotrig ETF Hook Blades Due to Sterile Seal Concerns

    Stryker GmbH is recalling 35 Endotrig ETF Hook Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2408-2019·2019-09-04

    Ad-Tech Skull Anchor Bolts Recalled for Incorrect MRI Approval Labeling

    Ad-Tech Medical Instrument Corporation is recalling Skull Anchor Bolts because supplemental information incorrectly indicated they were approved for use in the MR environment.

    Product
    Skull Anchor Bolts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2423-2019·2019-09-04

    Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 110 units of Endotrac EPF/EGR Hook Blades because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2019·2019-09-04

    Stryker Endotrac Triangle Blade Recall Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2019·2019-09-04

    Leventon DOSI-FUSER Infusion Pumps Recalled for Lack of FDA Clearance

    Leventon S. A. U. is recalling DOSI-FUSER infusion pumps because they lack FDA 510(k) clearance, making them misbranded.

    Product
    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
    Category
    Medical Device
    Distribution
    6 states
  • ModerateUSDA FSIS·089-2019·2019-08-31

    American Beef Packers Recalls Raw Beef Products Deemed Unfit for Human Consumption

    American Beef Packers is recalling approximately 24,428 pounds of raw beef products deemed unfit for human consumption after a carcass was erroneously released before test results were received.

    Product
    American Beef Packers, Inc. — American Beef Packers, Inc. Recalls Raw Beef Products Deemed Unfit for Human Consumption
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2069-2019·2019-08-28

    Nosh Organic Fruit & Protein Soft Oat Bars Recalled for Mold Contamination

    First Start Holdings is recalling Nosh Organic Fruit & Protein Soft Oat Bars due to potential mold contamination. Consumers should stop eating the product and return it to the store.

    Product
    Nosh Organic Fruit & Protein Soft Oat Bar; Blueberry & Banana. 6 - 0.74 oz. (21 g) bars per box. Net Wt. 4.44 oz. 126g) Ingredients: Organic Whole Grain Rolled Oats, Organic, Tapioca Syrup, Organic Sunflower Seed Protein, Organic Sunflower Oil, Organic Date Paste, Organic Dri
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2329-2019·2019-08-28

    BD Max Enteric Parasite Panel EU Extraction Tube Sealing Defect

    Becton Dickinson is recalling BD Max Enteric Parasite Panel EU kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1833-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls at the manufacturing facility.

    Product
    Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distrib
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2331-2019·2019-08-28

    BD MAX Reagent Extraction Tube Foil Bags Recall

    Becton Dickinson is recalling BD MAX Reagent extraction tube kits because foil bags may not be sealed properly.

    Product
    Kit BD Max CT/GC/TV; Catalog # 442970
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2332-2019·2019-08-28

    BD Max StaphSR Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD Max StaphSR kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max StaphSR; Catalog # 443418
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2347-2019·2019-08-28

    Aniara Diagnostica Recalls ZYMUTEST HIA MonoStrip ELISA Kits

    Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2354-2019·2019-08-28

    Molded Products Recalls Mislabelled Luer Lock Sets for IV Administration

    Molded Products Inc is recalling 130,000 Luer Lock Sets (Catalog # MPC-125) because some packages were incorrectly labeled as a different product.

    Product
    Luer Lock Set - Catalog # MPC-125, for IV administration sets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2357-2019·2019-08-28

    Cambridge Sensors Recalls Microdot Xtra Blood Glucose Test Strips

    Cambridge Sensors Limited is recalling Microdot Xtra blood glucose test strips in Illinois because faulty manufacturing equipment prevented the strips from fitting into the meter.

    Product
    Microdot Xtra blood glucose test strips
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2325-2019·2019-08-28

    BD Max ExK DNA 2 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD Max ExK DNA 2 USA kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max ExK DNA 2 USA; Catalog # 442819
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1825-2019·2019-08-28

    Medtech Recalls Clear Eyes Maximum Redness Relief Eye Drops

    Medtech Products is recalling Clear Eyes Maximum Redness Relief eye drops due to quality assurance concerns at the manufacturing facility.

    Product
    Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2346-2019·2019-08-28

    Aniara ZYMUTEST HIA MonoStrip IgG ELISA kit recalled for quality issues

    Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1829-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Me
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2019·2019-08-28

    BD MAX Reagent Extraction Tubes Recalled for Improper Sealing

    Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.

    Product
    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2323-2019·2019-08-28

    BD Max ExK DNA 1 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max ExK DNA 1 USA; Catalog # 442817
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2327-2019·2019-08-28

    BD Max ExK TNA 2 Extraction Tube Kit Recall for Sealing Defects

    Becton Dickinson is recalling BD Max ExK TNA 2 kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max ExK TNA 2; Catalog # 442825
    Category
    Medical Device
    Distribution
    38 states