The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

22426–22450 of 50429

  • HighCPSC·20165·2020-08-12

    Active Brands Recalls Sweet Protection Bicycle Helmets Due to Head Injury Risk

    Active Brands is recalling about 300 Sweet Protection bicycle helmets because they do not meet U.S. safety standards, posing a risk of head injury.

    Product
    Sweet Protection brand Ripper Jr., Ripper MIPS Jr., and Ripper MIPS bicycle helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2020·2020-08-12

    Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk

    Medline Industries Inc is recalling 1,400 endoscopic cleaning brushes because the brush may detach during use. The recall covers specific models and lots distributed nationwide.

    Product
    Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2743-2020·2020-08-12

    Normand-Info Remisol Advance Software Recall for Erroneous Lab Results

    Normand-Info is recalling Remisol Advance software version 1.12 because it deletes specific white blood cell and platelet results, potentially leading to erroneous data.

    Product
    Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·20V474000·2020-08-12

    2021 Winnebago Revel motorhomes recalled for detaching alternator belt

    Winnebago is recalling certain 2021 Revel motorhomes. The auxiliary alternator belt may wear and detach, which could cause loss of power steering control and increase the risk of crashes.

    Product
    WINNEBAGO — WINNEBAGO REVEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2020·2020-08-12

    Siemens Luminos dRF Max Recalled for Software Collision and Image Errors

    Siemens is recalling 49 Luminos dRF Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2020·2020-08-12

    Boss Instruments Recalls DeBakey Needle Holders Due to Plate Breakage Risk

    Boss Instruments is recalling 96 DeBakey needle holders because the tungsten carbide plate can break under pressure, posing a risk to patients and medical staff.

    Product
    BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2748-2020·2020-08-12

    Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Risk

    Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.

    Product
    Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2020·2020-08-12

    Mako Hip End Effector Recalled for Potential Bone Preparation Discrepancy

    Mako Surgical Corporation is recalling 12 units of Mako Hip End Effectors due to a characterization issue that may cause discrepancies during bone preparation in certain Mako Total Hip procedures.

    Product
    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2761-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1163-2020·2020-08-12

    Topway Enterprises Recalls Salmon Cut and Packaged in Styrofoam Cases

    Topway Enterprises is recalling approximately 16,700 lbs of cut salmon packaged in Styrofoam cases due to potential contamination with Listeria monocytogenes.

    Product
    Salmon cut and packaged in Styrofoam case approximately 19 kg per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2763-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1164-2020·2020-08-12

    Topway Enterprises Recalls Tuna for Potential Listeria Contamination

    Topway Enterprises is recalling approximately 1,300 lbs of cut tuna due to potential Listeria monocytogenes contamination. The product was distributed in five southern states.

    Product
    Tuna cut and packaged in Styrofoam case approximately 19 kg per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2754-2020·2020-08-12

    BD MAX SARS-CoV-2 Reagents Recalled for Potential False Positive Results

    Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.

    Product
    BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing prolonged procedures or tissue damage.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2765-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2760-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2756-2020·2020-08-12

    Siemens Luminos Agile Max Recalled for Software Collision and Image Errors

    Siemens Medical Solutions is recalling 477 Luminos Agile Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2020·2020-08-12

    Siemens Uroskop Omnia Max Recalled for Software Collision and Image Errors

    Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2764-2020·2020-08-12

    Boston Scientific Recalls Captiflex Snares Due to Potential Cutting Failure

    Boston Scientific is recalling specific lots of Captiflex Snares because they may fail to cut polyps, potentially causing tissue damage or bleeding.

    Product
    Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal…
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·20162·2020-08-12

    Intertex Recalls B-Air, BlueDri, and Soleaire Blowers Due to Fire Hazard

    Intertex is recalling approximately 189,000 B-Air, BlueDri, BlueDri Pro, and Soleaire blowers because unprotected side outlets pose a fire hazard.

    Product
    B-Air, BlueDri, BlueDri Pro and Soleaire Blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide