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.

28551–28575 of 50488

  • HighFDA (Devices)·Z-2185-2018·2018-06-20

    Roche Recalls Accu-Chek Aviva Plus Test Strips Due to Potential Errors

    Roche Diabetes Care is recalling specific lots of Accu-Chek Aviva Plus test strips because they may produce biased results or fail to detect blood, potentially leading to incorrect user actions.

    Product
    Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1581-2018·2018-06-20

    Sugarfina Sugar Cookies Recalled for Undeclared Egg Allergen

    Sugarfina is recalling Sugar Cookies due to an undeclared egg allergen. The product was distributed in the U.S. and the United Arab Emirates.

    Product
    Sugarfina Sugar Cookies Distributed by Sugarfina, Inc. small candy cube, large candy cube, and 1.0oz. taster packet UPC Code: 840278109414; 840278113725; 840278116580 9495 Santa Monica Blvd., Beverly Hills, CA 90210
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2198-2018·2018-06-20

    Angiodynamics Recalls BioFlo Midline Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2158-2018·2018-06-20

    Sun Med Recalls Medline Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 30 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2199-2018·2018-06-20

    Angiodynamics Recalls BioFlo Midline Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 23 boxes of BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2161-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Breakage Risk

    Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.

    Product
    Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2160-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Defect

    Maquet is recalling Aortic Arterial Cannulas because de-airing plugs may break during removal. The defect could compromise the device's integrity during cardiopulmonary bypass.

    Product
    Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2197-2018·2018-06-20

    Angiodynamics Recalls Microintroducer Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 86 boxes of Microintroducer Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2180-2018·2018-06-20

    Datascope Recalls Maquet Cardiopulmonary Bypass Tubing Kits Due to Valve Defect

    Datascope Corporation is recalling eight Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1566-2018·2018-06-20

    Meijer Dark Chocolate Covered Almonds Recalled for Undeclared Coconut

    Meijer is voluntarily recalling Dark Chocolate Covered Almonds because the product contains undeclared coconut, a major food allergen.

    Product
    Meijer Dark Chocolate Covered Almonds, 18 ounces, packed in a Clear plastic container, 12 containers per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2173-2018·2018-06-20

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 19 Proteus 235 proton therapy systems to provide safety information to maintenance technicians regarding ion source replacement.

    Product
    Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1549-2018·2018-06-20

    Morley Candy Makers Recalls Fudge Bites for Undeclared Almonds

    Morley Candy Makers is recalling Sanders Milk Chocolate Covered Fudge Bites because they contain undeclared almonds, a tree nut allergen.

    Product
    Milk Chocolate Covered Fudge Bites, 3.75oz, PET Pouch, 12 packages per case
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1544-2018·2018-06-20

    Divvies Semi-Sweet Peppermint Bars Recalled for Potential Milk Traces

    Divvies LLC is recalling 447 Semi-Sweet Peppermint Bars sold nationwide online because the product may contain traces of milk.

    Product
    simply delicious Divvies SEMI-SWEET PEPPERMINT BARS made to share CHOCOLATE bar BENJAMINT CRUNCH ALL NATURAL NUT & DAIRY FREE NET WT. 2.25 OZ. (63g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 80 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially causing the port to detach and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2194-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2148-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 5 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching during use and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2139-2018·2018-06-20

    Ion Beam Applications Recalls Proteus ONE and Plus Devices

    Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.

    Product
    Proteus ONE and Proteus Plus
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V413000·2018-06-19

    Forest River Recalls 2019 Prime Time Trailers Due to Stove Flame Hazard

    Forest River is recalling 2019 Prime Time recreational trailers because the stove is not isolated from the furnace return air, which can cause an inverted flame and increase the risk of injury.

    Product
    FOREST RIVER — FOREST RIVER PRIME TIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V414000·2018-06-19

    Forest River Prime Time Recalled for Incorrect Tire Pressure Label

    Forest River is recalling 2016-2018 Prime Time recreational trailers because the Federal Placard incorrectly states tire pressure as 65 PSI instead of 80 PSI.

    Product
    FOREST RIVER — FOREST RIVER PRIME TIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V405000·2018-06-15

    Mercedes-Benz Recalls 2018 GLA 250 for Missing Child Seat Anchor

    Mercedes-Benz is recalling 2018 GLA 250 vehicles because the center rear child seat tether anchor may be missing, preventing proper installation.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V408000·2018-06-15

    BMW Recalls G310R and G310GS Motorcycles for Side Stand Defect

    BMW is recalling 2017-2018 G310R and 2018 G310GS motorcycles because the side stand may damage the frame, causing the bike to fall over while stationary.

    Product
    BMW — BMW G310 GS, G310R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V396000·2018-06-14

    Dodge Journey Recall: Rear Camera View May Be Delayed

    Chrysler is recalling 2018 Dodge Journey vehicles because the rear camera view may not appear within two seconds of selecting reverse, increasing crash risk.

    Product
    DODGE — DODGE JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide