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.

10676–10700 of 22146

  • HighFDA (Devices)·Z-2427-2024·2024-07-31

    Medtronic A610 Clinician Programmer pocket adaptors limited to head-only MRI

    Medtronic recalled A610 Clinician Programmer software and pocket adaptors (Models 64001, 64002) due to MRI safety restrictions. Patients with these implants are limited to head-only MRI procedures.

    Product
    A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descripti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2024·2024-07-31

    Dxl 9000 Immunoassay Analyzer Recalled for Corrosion of USB Cable Contacts

    Beckman Coulter is recalling 143 Dxl 9000 Immunoassay Analyzers due to nonconforming USB cables with brass instead of gold contacts. Brass may corrode, potentially disabling internal communication and delaying patient test results.

    Product
    Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2024·2024-07-31

    Medtronic TourniKwik Tourniquet Set Recalled for Incorrect Component

    Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.

    Product
    TourniKwik Tourniquet Set (CFN 79012)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2024·2024-07-31

    LINK SymphoKnee Patella Sizing Template recalled due to incorrect markings

    LINK BIO CORP is recalling the LINK SymphoKnee Patella Sizing Template (Item Number 881-509/00, Lot C225066) because markings on two arms of the instrument were mixed up during manufacturing.

    Product
    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2428-2024·2024-07-31

    Beckman Coulter Clinical Reagent Recalled Due to Incorrect Lipemia Check Settings

    Beckman Coulter has recalled 13,565 units of IGM clinical reagent due to incorrect lipemia check settings that may produce false low results or report high results as normal. Affected units were distributed worldwide.

    Product
    Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2024·2024-07-31

    ABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results

    Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.

    Product
    ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1516-2024·2024-07-31

    Indigenous Collection Signature Plates recalled for potential lead contamination

    Canadian Art Prints is recalling Indigenous Collection Signature Plates sets due to potential leachable lead exceeding FDA guidance levels. The affected sets were distributed across 18 US states.

    Product
    UPC 772665860106. PLT010. Indigenous Collection Signature Plates set - Dancing Bears & Three Bears on box and back of plate. Art by Dawn Oman. Brand Indigenous Collection by CAP on box and back of plate. The Dancing Bears is a scene with three dancing polar bears with a night s
    Category
    Consumer Product
    Distribution
    18 states
  • HighFDA (Food)·F-1494-2024·2024-07-31

    Signature Blue Canned Crab Recalled for Improper Temperature Control

    Pacific Shellfish, Inc. is recalling Signature Blue Swimming Crab Claw and Lump canned crab (lots #78821 and #788454) from California due to storage at temperatures above 40°F without ice as of July 1, 2024.

    Product
    Signature Blue Swimming Crab Claw and Lump 1lb can Tin Can, Lot # 78821 Expiration June 09th 2026, Lot # 788454 Expiration June 09th 2026
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2430-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Fail Prematurely

    Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1515-2024·2024-07-31

    Glazed ceramic plates recalled for exceeding lead guidance levels

    Canadian Art Prints is recalling Indigenous Collection Signature Plates sets because the glazed ceramic plates may exceed FDA guidance levels for leachable lead. Consumers should stop using these plates immediately.

    Product
    UPC Code 772665860083, Stock code PLT008, Indigenous Collection Signature Plates set - Not Forgotten & Ancient Messages. Artist Maxine Noel on box and back of plates. Brand Indigenous Collection by CAP on box and back of plates. Not Forgotten is an image of a woman with indigeno
    Category
    Consumer Product
    Distribution
    18 states
  • HighFDA (Devices)·Z-2437-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk

    B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0617-2024·2024-07-31

    Venlafaxine Hydrochloride extended-release capsules recalled for failed dissolution specifications

    Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5mg due to failed dissolution specifications in lots M213175 and M213176. The recall affects 13,128 and 252 bottles distributed nationwide.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2024·2024-07-31

    Abbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life

    Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1613-2024·2024-07-31

    Bakery Cookie Recalled for Undeclared Peanut Allergen

    Shweetz Bakery-To-Go cookies are being recalled due to undeclared peanuts. The recall affects 11,070 cookies distributed across Pennsylvania, Maryland, Ohio, Virginia, and West Virginia.

    Product
    Shweetz Bakery-To-Go brand Peanut Butter Brownie Cheezecake Mashup Cookie Net Wt. 3 oz (85g) UPC: 759465005029. Individually packaged in a clear film wrap. 45 units per case. Frozen storage, thawed for retail sale.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1490-2024·2024-07-31

    Organic Aussie Bites recalled for undeclared gluten content

    Best Express Foods is recalling Universal Bakery Organic Aussie Bites due to undeclared gluten. Products labeled as gluten-free were found to contain gluten above regulatory limits.

    Product
    Universal Bakery Organic Aussie Bites, 30 oz clamshell container USDA Organic Certified Gluten Free Rolled Oats, Dried Apricots, Flax Seeds, Sunflower Seeds, Honey, Coconut, Quinoa, Chia Seeds + More! INGREDIENTS: Organic Rolled Oats, Organic Oat Flour, Organic Invert Cane Sugar
    Category
    Food
    Distribution
    13 states
  • HighCPSC·24312·2024-07-25

    2024 Kawasaki Mule PRO 1000 Utility Vehicles Recalled for Fire Hazard

    Kawasaki is recalling approximately 19,100 units of the 2024 Mule PRO 1000 utility vehicles due to improper combustion during engine start that can pose a fire hazard. Three fires have been reported with no injuries.

    Product
    2024 Kawasaki Mule PRO 1000 Off-Highway Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24311·2024-07-25

    Lancaster Table & Seating Plastic Restaurant High Chairs Recalled for Fall Hazard

    Clark Associates is recalling about 27,140 Lancaster Table & Seating Standard Height Plastic Restaurant High Chairs because the T-bar at the front can become loose, fall, or break off during use, posing a fall hazard to children.

    Product
    Lancaster Table & Seating Standard Height Plastic Restaurant High Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24316·2024-07-25

    Besrey Twins Strollers Recalled for Entrapment, Fall, and Choking Hazards

    Stiger Inc. is recalling about 3,045 Besrey Twins Strollers sold on Amazon due to entrapment, fall, and choking hazards that violate federal stroller safety regulations. Consumers should stop using the product immediately.

    Product
    Besrey Twins Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24317·2024-07-25

    2024 Arctic Cat Mountain 600 Snowmobiles Recalled Due to Crash Hazard

    Textron Specialized Vehicles is recalling about 600 of the 2024 Arctic Cat Mountain 600 Snowmobiles because a pin on the steering knuckle u-joint may not be properly installed, allowing it to come loose and cause loss of steering control.

    Product
    2024 Arctic Cat Mountain 600 Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24310·2024-07-25

    ProForm 50 LB Adjustable Dumbbells Recalled for Weight Plate Dislodgement

    iFIT Inc. is recalling ProForm Rapid Strike 50 LB Adjustable Dumbbell Sets because weight plates can dislodge during use, causing impact injuries. The firm has received eight reports of dislodgement, including three resulting in contusions and abrasions.

    Product
    ProForm Rapid Strike 50 LB Adjustable Dumbbell Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24313·2024-07-25

    Razor Icon Electric Scooters Recalled Due to Fall Hazard

    Razor is recalling about 7,300 Icon electric scooters because the downtube can separate from the floorboard during use, causing falls. The company has received 34 reports of downtube separation with two reported injuries.

    Product
    Razor Icon electric scooters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24318·2024-07-25

    Victor Electric Folding Soft Bullet Toy Guns Recalled for Eye Injury Hazard

    Victor Electric Folding Soft Bullet Toy Guns sold on Temu.com lack required blaze orange tips and have projectiles that fail to meet federal safety standards for toy weapons. The recalled toy guns pose an eye injury hazard to children.

    Product
    Victor Electric Folding Soft Bullet Toy Guns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2024·2024-07-24

    Surgical Awl Recalled Due to Insufficient Weld Integrity

    SeaSpine Orthopedics is recalling the Meridian Angled Awl Fixed surgical instrument due to insufficient weld around the cap component that may fail under impaction forces during surgery.

    Product
    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2397-2024·2024-07-24

    IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow

    B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
    Category
    Medical Device
    Distribution
    Distributed nationwide