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.

21601–21625 of 50426

  • HighFDA (Food)·F-0126-2021·2020-12-02

    Natural Grocers Organic Elderberries Recalled for Salmonella Contamination Risk

    Natural Grocers is recalling 4 oz. bags of Whole Organic Elderberries due to potential Salmonella contamination. Consumers should check their pantry for the specific UPC and lot codes.

    Product
    Natural Grocers, Elderberries Whole Organic, 4 oz. (113g), plastic bag, UPC 0-0082-00304-3
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0483-2021·2020-12-02

    Bayer Recalls MEDRAD Stellant FLEX Syringe Kits Due to Cracks

    Bayer Medical Care is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits because they may have holes or cracks that allow fluid to leak.

    Product
    Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2021·2020-12-02

    ViewRay MRIdian Linac System Recalled for Potential Burn Injury Risk

    Viewray, Inc. is recalling 35 ViewRay MRIdian Linac Systems because receive coil components may reach elevated temperatures, posing a risk of burn injury to patients or users.

    Product
    ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2021·2020-12-02

    Geistlich Bio-Oss Pen Recalled Due to Granule Expulsion Risk

    Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen 1-2mm 0.5g units because granules may be expelled all at once, posing a risk of tissue injury.

    Product
    Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21039·2020-12-02

    ADCO Recalls Sure Scents Candles Due to Fire and Burn Hazards

    ADCO is recalling Sure Scents 2-1 Peaceful Stream/Moonlit Waves candles sold at Dollar Tree because high flames can ignite wax or break glass, posing fire and burn risks.

    Product
    Sure Scents 2-1 Peaceful Stream/Moonlit Waves Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2021·2020-12-02

    Eywa Pharma Recalls Levetiracetam Tablets Due to Foreign Tablet Presence

    Eywa Pharma Inc. is recalling 500 mg Levetiracetam tablets because a 1000 mg tablet was found in a 500 mg bottle.

    Product
    Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2021·2020-12-02

    FDA Recalls Geistlich Bio-Oss Pen Due to Granule Expulsion Risk

    Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.

    Product
    Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21040·2020-12-02

    Huffy Recalls Torex Ride-on Toy UTVs Due to Injury Hazard

    Huffy is recalling Torex 24V ride-on toy UTVs sold at Walmart because the toys can unexpectedly move when the battery is connected, posing an injury hazard.

    Product
    Huffy Torex 24V ride-on toy UTVs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2021·2020-12-02

    Coloplast Titan Pump Recall for Potential Device Fracture

    Coloplast is recalling 8,962 Titan Pump units due to a potential increased occurrence of pump fracture over the device's lifetime.

    Product
    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2021·2020-12-02

    RayStation software recall for potential incorrect treatment plan references

    RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.

    Product
    RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2021·2020-12-02

    Mevion Proton Radiation Treatment System Recalled for Screen Display Failure

    Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2021·2020-12-02

    Intuitive Surgical Recalls ION Fully Articulating Catheters Due to Tip Ring Risk

    Intuitive Surgical is recalling 454 ION Fully Articulating Catheters because the distal tip ring may become dislodged during use.

    Product
    Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0125-2021·2020-12-02

    Roshni Foods Green Raisins Recalled for Undeclared Sulfites

    Singh Trading Inc. DBA Roshni Foods is recalling Green Raisins due to undeclared sulfites. The product was distributed to retail stores in NC, MD, VA, and PA.

    Product
    Green Raisins 200 grams (7 oz.) Packaged in plastic bags. Bar Code:992203621
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0481-2021·2020-12-02

    ViewRay MRIdian System Recalled for Potential Burn Injury Risk

    ViewRay is recalling three MRIdian systems because receive coil components may reach elevated temperatures, posing a potential risk of burn injury to patients or users.

    Product
    ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V745000·2020-12-01

    Halcore Recalls 2020 Horton Emergency Vehicles Due to Display Failure

    Halcore is recalling 2020 Horton Type I and III emergency vehicles because a display processor may stop working, potentially delaying emergency services.

    Product
    HORTON — HORTON TYPE III, TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V742000·2020-11-30

    2021 Freightliner Cascadia clutch defect may cause disengagement

    Daimler Trucks North America is recalling 2021 Freightliner Cascadia trucks due to a manufacturing defect in the clutch assembly that may cause the clutch to disengage, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V740000·2020-11-30

    Triumph Rocket 3 Motorcycles Recalled for Air in Antilock Brake System

    Triumph is recalling certain 2020-2021 Rocket 3 motorcycles because air may have entered the rear brake ABS modulator during production. This can reduce braking efficiency over time, increasing stopping distance and crash risk.

    Product
    TRIUMPH — TRIUMPH ROCKET 3 R, ROCKET 3 GT, ROCKET 3 TFC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2021·2020-11-25

    Cardinal Health Recalls Kangaroo Connect 500ml Bag Sets Due to Leakage

    Cardinal Health is recalling Kangaroo Connect 500ml Bag Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2021·2020-11-25

    Stryker Recalls Osteosynthesis Compression Staple EasyClip Devices

    Stryker GmbH is recalling EasyClip and EasyClip Xpress staples due to potential nickel release above safety margins in pediatric patients under 20 kg.

    Product
    Osteosynthesis Compression Staple EasyClip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V737000·2020-11-25

    Audi recalls S5, A5, and RS5 for rear wiring defect

    Volkswagen Group (Audi) is recalling 2020-2021 S5, A5, and RS5 vehicles due to missing anti-abrasion protection on rear light wiring. In a crash, exposed wires may be damaged, potentially disabling door locks and hazard lights.

    Product
    AUDI — AUDI A5, RS 5, S5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0116-2021·2020-11-25

    Art Of Tea Feel Better tea recalled for potential Salmonella

    Art Of Tea is recalling Feel Better tea due to potential Salmonella contamination in elder berries. Consumers should stop using the product.

    Product
    Art Of Tea - Feel Better tea; Produced and Distributed by: Art of Tea LLC, Monterey Park, CA Directions: 1 Tbsp of tea in 8 oz. of water at 206 degrees; steep for 5-7 minutes. Packaged in: Black Mylar bag with label, Silver Mylar bag with label, Silver Tin Canisters…
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0454-2021·2020-11-25

    MeritMedical Cultura Flex Swab Recall Due to Tip Breakage Risk

    Merit Medical Systems is recalling Cultura Flex Swabs because the flocked tip may break off during use, potentially causing soft tissue injury or treatment delays.

    Product
    MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0120-2021·2020-11-25

    John Nagle Steelhead Fillets Recalled for Listeria Contamination Risk

    John Nagle Co. is recalling steelhead fillets that may be contaminated with Listeria monocytogenes. The product was distributed in Massachusetts, New York, Pennsylvania, and Ohio.

    Product
    John Nagle Steelhead Fillets; 1/3 lb; Iceland; N44515; Habrun ehf; Packaging date: 29 10 2020
    Category
    Food
    Distribution
    4 states