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.

16101–16125 of 53092

  • HighFDA (Devices)·Z-1672-2022·2022-09-07

    Medical device software error affects toric IOL surgical planning accuracy

    A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.

    Product
    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Drugs)·D-1468-2022·2022-09-07

    Colgate Anticavity Fluoride Toothpaste Recalled for Improper Storage Conditions

    Family Dollar is recalling Colgate OPTIC WHITE CHARCOAL COOL MINT toothpaste (Net Weight 4.2 oz., UPC 0 35000 97872 1) distributed to stores in 11 states due to improper temperature storage during manufacturing.

    Product
    Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1667-2022·2022-09-07

    Hip Implant Stem Recalled for Failed Fatigue Testing

    Corin Ltd is recalling a hip implant stem component (Model 588.3800) after some units failed fatigue testing. The affected devices were distributed to New Jersey only.

    Product
    TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1641-2022·2022-09-07

    TB Diagnostic Test Recalled Due to Storage Temperature Excursion

    Oxford Immunotec recalled 81 T-SPOT.TB diagnostic test kits (Lot TEC4000098) due to storage equipment failure that kept products outside the validated 2-8°C temperature range. The excursion may affect test accuracy.

    Product
    T-SPOT.TB REF TB.300 US
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1674-2022·2022-09-07

    Pentacam HR Medical Device Software Error Impacts Surgical Planning

    A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.

    Product
    Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1644-2022·2022-09-07

    Medtronic EverFlex Peripheral Stents Recalled for Partial Deployment Risk

    Medtronic is recalling EverFlex peripheral stents worldwide due to risk of partial deployment. Updated instructions provide a manual deployment workaround to mitigate potential harms.

    Product
    EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V670000·2022-09-07

    BMW X7 Third-Row Seat Backrest Springs May Not Lock Properly

    BMW is recalling 2019-2022 X7 models with third-row seats because compression springs may not have been properly installed, causing the seat backrest to potentially fail to lock in a crash.

    Product
    BMW — BMW X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2022·2022-09-07

    Philips Radiography System Firmware Defect Risks Incorrect Radiation Dose

    Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.

    Product
    DigitalDiagnost C50 1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1685-2022·2022-09-07

    Sucrose solution vials recalled nationwide for contamination and leaking

    Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to reports of leaking containers and contamination with black liquid and particulates. The product is used in hospital settings including neonatal intensive care units.

    Product
    Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2022·2022-09-07

    AggreGuide A-100 Instrument Software Issue Affecting Test Results

    Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.

    Product
    AggreGuide A-100 Instrument
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1642-2022·2022-09-07

    T-Cell Xtend Test Kit Recalled Due to Improper Storage Temperature

    Oxford Immunotec is recalling 47 units of the T-Cell Xtend REF TTK.610 US test kit due to equipment failure that caused improper storage temperatures outside the validated range. Affected devices may have been compromised.

    Product
    T-Cell Xtend REF TTK.610 US
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-1465-2022·2022-09-07

    Colgate OPTIC WHITE PRO Series Toothpaste Recalled for Improper Storage

    Family Dollar Stores is recalling 1,120 packages of Colgate OPTIC WHITE PRO SERIES toothpaste due to improper temperature storage conditions that deviate from cGMP standards.

    Product
    Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2022·2022-09-07

    Aesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion

    Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.

    Product
    Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1683-2022·2022-09-07

    Great Value Chopped Walnuts Recalled Due to Pecan Mislabeling

    Great Value Chopped Walnuts pouches containing pecans have been recalled from Walmart distribution centers in North Carolina and Florida. The product was mislabeled, which may affect consumers with nut allergies.

    Product
    Great Value Chopped Walnuts, NET WT 4oz (113g); Ingredients: Walnuts DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716; UPC 0 78742 20134 4
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1650-2022·2022-09-07

    FGFR cancer diagnostic kit recalled due to increased false positive results

    Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.

    Product
    therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
    Category
    Medical Device
    Distribution
    4 states
  • HighUSDA FSIS·030-2022·2022-09-06

    Magnolia Provision Company recalls beef jerky products due to possible Listeria contamination

    Magnolia Provision Company, Inc. is recalling beef jerky products because laboratory testing detected possible Listeria monocytogenes contamination.

    Product
    Magnolia Provision Co., Inc. — Magnolia Provision Company, Inc., Recalls Beef Jerky Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V669000·2022-09-06

    Alamo Group Recalls All JetVac Vehicles Due to Hose Reel Defect

    Alamo Group is recalling 2019-2022 All JetVac vehicles because a short clevis can cause the hose reel to fall, increasing injury risk.

    Product
    ALAMO GROUP — ALAMO GROUP ALLJETVAC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V666000·2022-09-01

    2021-2022 Nissan Rogue Rear Seat Belts May Fail to Retract

    Nissan is recalling certain 2021-2022 Rogue vehicles where rear seat belts may not retract properly, making them difficult to use. This could prevent proper seatbelt usage in a crash. Dealers will replace affected seat belts for free.

    Product
    NISSAN — NISSAN ROGUE, redundant ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V665000·2022-09-01

    Motorhome recall: missing engine air intake drain increases crash risk

    Jayco is recalling 2021-2023 Entegra and Jayco motorhomes for a missing water drain in the engine air intake box. Water can accumulate and enter the engine, causing engine failure and increasing crash risk.

    Product
    ENTEGRA — ENTEGRA, JAYCO ASPIRE, REATTA, CORNERSTONE, EMBARK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22768·2022-09-01

    Yuboloo Infant Bath Seats Recalled for Drowning Hazard

    Yuboloo is recalling about 1,050 infant bath seats sold on Amazon.com from May to November 2021 because they fail to meet federal safety standards and can tip over in water, posing a drowning hazard to infants.

    Product
    Infant Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22769·2022-09-01

    Otter MOMO Children's Sandals Recalled for Excess Lead Content

    Kolan LLC is recalling about 100 Otter MOMO children's sandals sold on Amazon.com from March through April 2022 because the inner layer exceeds federal lead content limits. Lead can be toxic if ingested by young children.

    Product
    Otter MOMO Children's Sandals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V661000·2022-09-01

    2022 Lexus NX and Toyota Tundra Electronic Parking Brake Failure

    Certain 2022 Lexus NX and Toyota Tundra vehicles' electronic parking brake systems may fail to engage because the Skid Control ECU falsely detects an overcurrent condition. This increases the risk of vehicle rollaway.

    Product
    LEXUS — LEXUS, TOYOTA NX350, TUNDRA, NX250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22214·2022-09-01

    TJX Recalls Novogratz Outdoor Metal Hanging Chairs Due to Fall Hazard

    TJX Companies is recalling about 5,000 Novogratz outdoor metal hanging chairs sold nationwide. These chairs can tip or fall while occupied, or the supporting hooks or chains can break, causing 16 reported injuries including bruises and a mild concussion.

    Product
    Novogratz brand Outdoor Metal Hanging Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide