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.

25076–25100 of 50443

  • HighFDA (Food)·F-2058-2019·2019-08-28

    Keto Farms Recalls Snack Mix Due to Undeclared Coconut Allergen

    Keto Farms LLC is recalling specific varieties of Keto Snack Mix because the label failed to declare coconut, a major allergen. The recall covers 2,762 units distributed in the US, Canada, and several other countries.

    Product
    Keto Farms Keto Snack Mix - Tomato Pepperjack Fruit & Cheese Mix with Sprouted Pecans & Walnuts; Net Wt. 95 g (3.34 oz. Ingredients: Monterey Jack Cheese with Jalapeno Peppers, (Pasteurized Milk, Jalapeno Peppers, Cheese Culture, Salt, Enzymes), Sprouted Organic Walnuts…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer PST Blood Collection Tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2072-2019·2019-08-28

    Elevation Foods Recalls Fresket Tuna Salad Due to Listeria Risk

    Elevation Foods is recalling Fresket Tuna Salad because Listeria monocytogenes was found in egg salad produced on the same line.

    Product
    Fresket Tuna Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2345-2019·2019-08-28

    Siemens MAGNETOM Prisma MRI Devices Recalled for Quench Venting Port Issue

    Siemens is recalling 17 MAGNETOM Prisma MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.

    Product
    MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2297-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2019·2019-08-28

    Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling 1,384 ACUSON NX3 diagnostic ultrasound systems worldwide because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2019·2019-08-28

    Thoratec HeartMate 3 LVAS Implant Kit Recalled for Outflow Graft Leaks

    Thoratec Corp. is recalling HeartMate 3 LVAS Implant Kits because an insufficiently seated C-Ring can cause the outflow graft to leak during implantation, rendering the device nonfunctional.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2019·2019-08-28

    Radiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities

    Radiometer America Inc is recalling ABL90 FLEX Analyzers due to software security vulnerabilities that may cause device shutdowns or reboots, potentially delaying medical treatment.

    Product
    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2307-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2064-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas Due to Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics,Mojo Magic Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2068-2019·2019-08-28

    Nosh Organic Fruit and 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. The product was distributed nationwide through three US distributors and the company's website.

    Product
    Nosh Organic Fruit & Protein Soft Oat Bar; Apple, Sweet Potato & Cinnamon. 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…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·19188·2019-08-27

    Happy Plugs Recalls Wireless Headphones Due to Burn Hazard

    Happy Plugs is recalling Bluetooth Wireless II headphones because the included micro-USB charging cable can cause overheating and burns. No injuries have been reported.

    Product
    Happy Plugs Bluetooth Wireless II Headphones
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19E057000·2019-08-26

    MAC Tools tire pressure gauges recalled due to inaccurate pressure readings

    Stanley Assembly Technologies is recalling certain MAC Tools tire pressure gauges because they may display lower than actual pressure when battery voltage is low, potentially causing tires to burst.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V623000·2019-08-26

    Lance Camper Recalls 2018-2019 855S Trailers Due to Fire Risk

    Lance Camper is recalling 2018-2019 855S trailers because a wire may contact the refrigerator burner box, increasing fire risk.

    Product
    LANCE CAMPER — LANCE CAMPER LANCE CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V620000·2019-08-22

    Thomas Built Minotour School Buses Recalled for Missing Backup Cameras

    Daimler Trucks North America is recalling 2019-2020 Thomas Built Minotour school buses because they may be missing backup cameras, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 240 units of K-Wire Single Trocar 2.5x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2281-2019·2019-08-21

    Canadian Hospital Specialties Recalls Polyurethane Feeding Tubes Due to Connector Detachment

    Canadian Hospital Specialties is recalling specific lots of MED-RX polyurethane feeding tubes because the connector may detach from the tube.

    Product
    MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2254-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x32 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide