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.

33301–33325 of 50502

  • HighFDA (Devices)·Z-1085-2017·2017-02-01

    Atrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue

    Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.

    Product
    Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2017·2017-02-01

    Philips Recalls Velara Generators Due to Potential System Lockup

    Philips is recalling 59 Velara Generators used with Allura Xper Systems because the devices may lock up. The recall is voluntary and covers units in the US and internationally.

    Product
    Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1339-2017·2017-02-01

    Ambrosia Worcestershire Sauce Recalled for Undeclared Peanuts

    Schreiber Food International is recalling Ambrosia brand Worcestershire sauce because it may contain undeclared peanuts.

    Product
    Ambrosia Quality Foods Brand 4/1 gallon Worcestershire Sauce Net 128 Fl. Oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2017·2017-02-01

    Philips Cisco 3850 Switch Recall Due to Monitoring Loss Risk

    Philips is recalling Cisco 3850 switches used with IntelliVue systems because they may experience a loss of centralized monitoring.

    Product
    Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1083-2017·2017-02-01

    Atrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging

    Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.

    Product
    Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1340-2017·2017-02-01

    Farm to Market Foods Recalls Green Bean Casserole for Undeclared Peanuts

    Farm to Market Foods is recalling Green Bean Casserole products in Texas due to undeclared peanuts. The recall affects specific lots and expiration dates.

    Product
    Farm to Market Foods Green Bean Casserole Code #1958 Net Wt. 6/1.95 lb. Trays with 6/.05 oz. Frenchs Fried Onions; Farm to Market Foods Green Bean Casserole Code #1971 Net Wt. 4/3.85 lb. Bags with 4/.15 oz. Frenchs Fried Onions UPC: 617037959029
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1062-2017·2017-02-01

    Philips Velara Generator Recall for System Lockup Risk

    Philips is recalling 59 Velara Generators with old firmware used with the Integris BH5000 because the system may lock up.

    Product
    Velara Generator with an old Firmware version used with the Philips Integris BH5000
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1091-2017·2017-02-01

    Merge Hemo software recall due to potential connection issues

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.

    Product
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2017·2017-02-01

    Hitachi Oasis MRI C-Spine Coil Recalled Due to Overheating Balun

    Hitachi Medical Systems America Inc is recalling 180 Hitachi Oasis MRI System C-Spine Coils because the coil balun was found to be hot to the touch after an exam.

    Product
    Hitachi Oasis MRI System - C-Spine Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2017·2017-02-01

    Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits

    Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks during dialysis.

    Product
    Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1310-2017·2017-02-01

    Dutch-American Foods Recalls Blueberry Donut Bases for Salmonella Risk

    Dutch-American Foods is recalling Blueberry Donut baking bases due to potential Salmonella contamination. The product was distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    Blueberry Donut , ST8300-50, NET WT. 50 LBS
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1354-2017·2017-02-01

    Tortillas Tita Recalls Corn Tortillas for Undeclared Wheat Allergen

    Tortillas Tita is voluntarily recalling specific lots of corn tortillas and tortilla enchilada produced between September 2016 and December 7, 2016, due to undeclared wheat.

    Product
    Corn Tortillas, 18 Count-16 Oz./453 g 16 units per case, 10 Count- 8 Oz./283 g 20 units per case, Mini- 12 Oz. 18 units per case, packed in plastic bags
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1334-2017·2017-02-01

    Dear North Alaska Salmon Bites Recalled for Undeclared Soy

    Authentic Alaska is recalling Dear North Alaska Salmon Bites due to undeclared soy from tamari sauce. The product was distributed in California and Maryland.

    Product
    Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor, Dear North brand, Item # 2001, net wt. per pouch: 2 oz. UPC 8 15036 02001 0
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1341-2017·2017-02-01

    Farm to Market Foods Recalls Smoked Ham Dinner for Undeclared Peanuts

    Farm to Market Foods is recalling Smoked Ham Dinner #1977 Holiday products in Texas due to undeclared peanuts.

    Product
    Farm to Market Foods Smoked Ham Dinner #1977 Holiday Ingredients: Smoked Spiral Diced Ham, Mashed Potatoes, Orange Cranberry Relish, Broccoli Rice Casserole, Green Bean Casserole. Keep Refrigerated at 38 Deg F or Less UPC: 617037959081
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1090-2017·2017-02-01

    Roche Recalls Five cobas p 612 Pre-analytical Systems in Texas and Washington

    Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.

    Product
    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1338-2017·2017-02-01

    Gonsalves Sugar Coated Almonds Recalled for Undeclared Wheat and Dyes

    The Henry Gonsalves Co. is recalling Gonsalves Sugar Coated Almonds because the product contains undeclared wheat and artificial dyes.

    Product
    Gonsalves Sugar Coated Almonds, Net Wt. 12 oz. Distributed by The Gonsalves Company, Smithfield, RI 02917 UPC number 20539-64550
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1092-2017·2017-02-01

    Roche Tina-Quant CRP Latex Test System Recalled for Low Results

    Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.

    Product
    Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17077·2017-01-31

    Brown Jordan Recalls Swivel Patio Chairs Due to Fall Hazard

    Brown Jordan Services is recalling La-Z-Boy swivel patio chairs sold at Sears.com because the base can break during normal use, posing a fall hazard.

    Product
    Swivel Patio Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V064000·2017-01-31

    Van Hool Motorcoach Recall for Steering Box Defect in Cold Weather

    Van Hool is recalling specific 2010-2017 motorcoaches because the steering wheel may be difficult to turn in low temperatures, increasing crash risk.

    Product
    VAN HOOL — VAN HOOL CX45, TD925, TX45, T2145
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17076·2017-01-31

    Casual Living Recalls Swivel Patio Chairs Due to Fall Hazard

    Casual Living Worldwide is recalling about 2 million swivel patio chairs sold at Home Depot because the base can break, causing falls.

    Product
    Swivel Patio Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17079·2017-01-31

    Teufelberger Recalls Static Ropes and Throwlines Due to Fall Hazards

    Teufelberger is recalling specific static ropes and throwlines because they are mislabeled as certified to NFPA safety standards, posing fall and injury risks to users.

    Product
    Static ropes and throwlines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V061000·2017-01-26

    GM Recalls Pontiac Solstice and Saturn Sky for Air Bag Sensor Defect

    General Motors is recalling 2006-2010 Pontiac Solstice and 2007-2010 Saturn Sky vehicles because a bent passenger air bag sensor may prevent the air bag from deploying in a crash.

    Product
    PONTIAC — PONTIAC, SATURN SOLSTICE, SKY
    Category
    Vehicle
    Distribution
    Distributed nationwide