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.

29726–29750 of 50499

  • HighFDA (Devices)·Z-0694-2018·2018-03-07

    Integra CUSA Clarity Footswitch Recalled for Unintended Activation

    Integra LifeSciences is recalling 155 CUSA Clarity footswitches because a defect may cause unintended ultrasonic fragmentation activation during surgery.

    Product
    Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0837-2018·2018-03-07

    M&P Food Productions Recalls Vareniki Potato and Onion for Undeclared Wheat

    M&P Food Productions is recalling Vareniki Potato and Onion because the product contains undeclared wheat. This poses a risk to individuals with wheat allergies or celiac disease.

    Product
    M&P Food Productions brand Vareniki Potato and Onion, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0 7163 02616 7
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0795-2018·2018-03-07

    Avid Medical Recalls TruCustom NEURO Kits Due to Foreign Material

    Avid Medical is recalling 46 TruCustom NEURO PK convenience kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0702-2018·2018-03-07

    Moog Curlin Infusion Sets Recalled for Particulate Contamination

    Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets due to particulate matter found on the spike.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2018·2018-03-07

    Avid Medical Recalls TruCustom Upper Extremity Kits Due to Foreign Material

    Avid Medical is recalling 216 TruCustom Upper Extremity convenience kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04
    Category
    Medical Device
    Distribution
    10 states
  • HighCPSC·18726·2018-03-07

    Husqvarna Recalls FS 450 Competition Motorcycles Due to Brake Failure Hazard

    Husqvarna is recalling approximately 160 FS 450 closed course competition motorcycles from model years 2016 to 2018 because a cracked front brake piston can cause brake failure and crashes.

    Product
    Husqvarna FS 450 closed course competition motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2018·2018-03-07

    Moog Curlin Infusion Sets Recalled for Particulate Matter on Spike

    Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets because particulate matter was found on the spike. The recall covers 7,979 cases distributed nationwide and internationally.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2018·2018-03-07

    Stryker Recalls Berchtold Chromophare Monitor Arms Due to Weld Defects

    Stryker Communications is recalling 850 Berchtold Chromophare Dual Monitor Carrier Arms and Flat Panels because the mounts may have missing or incomplete welds.

    Product
    Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V157000·2018-03-07

    Thomas Built Buses Minotour Recalled for Wheelchair Lift Safety Defect

    Daimler Trucks North America is recalling 2007-2018 Thomas Built Buses Minotour school buses because the wheelchair lift may operate while the vehicle is in motion.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2018·2018-03-07

    ConMed Recalls STAT 2 I.V. Gravity Flow Sets Due to Inaccurate Flow Rates

    ConMed is recalling STAT 2 I.V. Gravity Flow Needle-Free Controller sets because they exhibit inaccurate or inconsistent flow rates.

    Product
    STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0840-2018·2018-03-07

    M&P Food Productions Vareniki Recalled for Undeclared Wheat

    M&P Food Productions is recalling Vareniki - farmer cheese due to undeclared wheat. Consumers with celiac disease or wheat allergies should not consume the product.

    Product
    M&P Food Productions brand Vareniki - farmer cheese, Hand made, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0716 302618 1
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0835-2018·2018-03-07

    M&P Food Productions Recalls Vareniki Sour Cherry for Undeclared Allergens

    M&P Food Productions is recalling Vareniki Sour Cherry because the product contains undeclared wheat and Red #40.

    Product
    M&P Food Productions brand Vareniki Sour Cherry, Net Wt. 14oz (396g), Keep Frozen, UPC: 7 07163 02615 0
    Category
    Food
    Distribution
    10 states
  • HighNHTSA·18V154000·2018-03-07

    BMW Recalls 2018 X3 Models for Potential Rear Spoiler Detachment

    BMW is recalling 2018 X3 xDrive30i and M40i vehicles because the rear spoiler may not be properly attached or may be missing screws, posing a road hazard.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2018·2018-03-07

    Cosmedent Etching Gel Recalled Due to Syringe Tip Detachment Risk

    Cosmedent, Inc. is recalling 84 units of Etching Gel because the syringe tips may detach during use.

    Product
    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0816-2018·2018-03-07

    Hitachi Ultrasound Transducer Recalled for Electrical Shock Hazard

    Hitachi Medical Systems America Inc is recalling 55 ultrasound transducers (Model UST-5550-R) because they may not have adequate protection against electrical shock hazards.

    Product
    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-0836-2018·2018-03-07

    M&P Food Productions Recalls Vareniki Cabbage for Undeclared Wheat

    M&P Food Productions is recalling Vareniki Cabbage because the product contains undeclared wheat. Consumers with celiac disease or wheat allergies should not eat the product.

    Product
    M&P Food Productions brand Vareniki Cabbage, Net WT 14 oz. (396g), Keep Frozen, UPC: 7 07163 02619 8
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0838-2018·2018-03-07

    M&P Food Productions Recalls Blintzes Due to Undeclared Wheat

    M&P Food Productions is recalling Hand Made Russian Style Blintzes because they contain undeclared wheat. Consumers should check their pantries for the affected product.

    Product
    M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese, Net Wt. 14 oz. (396 g); UPC Codes: 7 07163 30325 1, Keep Frozen
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0830-2018·2018-03-07

    Lunds & Byerlys White Quinoa Recalled for Undeclared Wheat Allergen

    InHarvest, Inc. is recalling Lunds & Byerlys White Quinoa because some bags contain Israeli Couscous, which includes wheat, without declaring the allergen.

    Product
    White Quinoa; 16 oz. (454g) bags with clear panel in front; UPC: 0 72431 00195 6 Brand name Lunds & Byerlys Quinoa ingredients: White Quinoa Couscous ingredients: Israeli Couscous (wheat flour, rosemary extract). Contains: Wheat. Produced for Lunds & Byerlys…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0823-2018·2018-03-07

    LifeCell Revolve Advanced Adipose System Recalled for Bacterial Endotoxins

    LifeCell is recalling 25,798 units of the Revolve Advanced Adipose System due to bacterial endotoxin levels above acceptable limits.

    Product
    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0869-2018·2018-03-07

    Margalaxy Cosmic Crunch Granola Recalled for Undeclared Coconut Flakes

    Margalaxy LLC is recalling Cosmic Crunch Granola due to undeclared coconut flakes. The product was distributed in Oregon.

    Product
    Cosmic Crunch Granola, packaged in paper bag, net wt 10 oz. The product is labeled in parts: "***COSMIC CRUNCH superfood granola***10oz***Margalaxy***Ingredients: Walnuts, Almonds, Maple Syrup, Maca Powder, Flax meal, Cinnamon, Sea Salt, Vanilla, Coconut Oil, Chia Seeds…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0701-2018·2018-03-07

    Moog Curlin Infusion Administration Set Recalled for Particulate Matter

    Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets due to particulate matter found on the spike.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2018·2018-03-07

    Avid Medical Recalls TruCustom Plastic Basin Kits Due to Foreign Material

    Avid Medical is recalling 440 TruCustom Plastic Basin Packs because some kits contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0708-2018·2018-03-07

    Siemens Axiom Artis Medical Devices Recalled for Liquid Entry Risk

    Siemens Medical Solutions is recalling Axiom Artis devices due to a potential for liquid entry.

    Product
    Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2018·2018-03-07

    Fresenius 2008T Hemodialysis Systems Recalled for Software Anomaly

    Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.

    Product
    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide