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.

33201–33225 of 50502

  • HighFDA (Devices)·Z-1207-2017·2017-02-22

    Atrium Medical Recalls Maquet Oasis Chest Drains Due to Valve Defect

    Atrium Medical is recalling Maquet Oasis chest drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: 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-1211-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OASIS Drain

    Atrium Medical Corporation is recalling 18 units of Maquet Express Dry Seal Suction OASIS Drain because the manual vent valve may fail to re-seal.

    Product
    Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: 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 collection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2017·2017-02-22

    Siemens ARTISTE MV System Recalled for Collimator and Weld Defects

    Siemens is recalling 194 ARTISTE MV radiation therapy systems due to incorrect collimator position displays and improper weld seams.

    Product
    ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1199-2017·2017-02-22

    Acumed Recalls 6-Hole Pubic Symphysis Plates Due to Material Error

    Acumed LLC is recalling 15 units of 6-hole Pubic Symphysis plates because they were manufactured with the wrong titanium alloy.

    Product
    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1468-2017·2017-02-22

    Pictsweet Farms Breaded Okra Recalled for Potential Glass Fragments

    The Pictsweet Company is recalling Southern Classics Crunchy Breaded Okra because the product may contain glass fragments.

    Product
    PICTSWEET(R) FARMS, Southern Classics, Crunchy Breaded Okra, NET WT 12 OZ (340g), UPC 7056098377
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1208-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction Chest Drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: 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 (Food)·F-1480-2017·2017-02-22

    Joe Chips Potato Chips Recalled for Potential Salmonella Contamination

    The Two Little Guys Company is recalling Joe Chips Sour Cream & Toasted Onion potato chips because a milk powder ingredient may be contaminated with Salmonella.

    Product
    Joe Chips Retro Potato Chips Sour Cream & Toasted Onion Distributed by: The Joe Tea Company, Upper Montclair, NJ 07043-0255 (973)744-7502 Net Wt. 2 OZ UPC 743234001725 Net Wt. 5 OZ UPC 743234001800
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2017·2017-02-22

    Siemens Oncor Avant-garde Radiation Therapy Systems Recalled for Sensor Defects

    Siemens is recalling 194 Oncor Avant-garde radiation therapy systems due to incorrect collimator position displays and improper weld seams.

    Product
    ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·17090·2017-02-21

    Yamaha Recalls Grand Piano Benches Due to Lead Paint Violation

    Yamaha Corporation of America is recalling about 900 piano benches sold with grand pianos because the interior paint contains excessive lead, violating federal standards.

    Product
    Piano benches sold with Yamaha grand piano
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17E009000·2017-02-16

    Hale Fire Pump Pressure Switch Recall for Cold Weather Failure

    Hale Products Inc. is recalling Fire Pump Engagement Pressure Switches that may fail in extremely cold temperatures, potentially delaying water delivery during fires.

    Product
    EQUIPMENT:MECHANICAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V104000·2017-02-16

    Volvo Recalls 2017 Models Due to Air Bag Bolt Failure Risk

    Volvo is recalling 2017 XC90, S90, and V90 Cross Country vehicles because side air bag bolts may break, causing improper deployment in a crash.

    Product
    VOLVO — VOLVO V90CC, S90, XC90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1451-2017·2017-02-15

    Marich Chocolate Caramel Heart Recalled for Unlabeled Almond Allergen

    Marich Confectionery is recalling Chocolate Caramel Hearts because some boxes contained Triple Chocolate Toffee with almonds, which are not listed on the Caramel Heart label.

    Product
    MARICH Premium Chocolates; Chocolate Caramel Heart; Our delicious caramel hearts in rich milk and dark chocolate; Net Wt 4.25 oz. (120g) UPC 797817-44440-9
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1137-2017·2017-02-15

    AngioDynamics Recalls Celerity ECG Cable Accessory Packs Due to Soldering Defect

    AngioDynamics is recalling Celerity ECG Cable Accessory Packs because the ECG clip cable may not be soldered correctly, potentially preventing the device from conducting ECG signals.

    Product
    Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1443-2017·2017-02-15

    Dawson Foods Recalls Creamy White Frosting Mix for Salmonella Risk

    Dawson Foods is voluntarily recalling Creamy White Frosting Mix and Kustard Kwik Mix because a supplier recalled dried milk for potential Salmonella contamination.

    Product
    Dawson Foods Inc. Creamy White Frosting Mix , 5 Lb Bags, 6 5Lb bags per case Creamy White, Ambient Storage
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0927-2017·2017-02-15

    Bayer Recalls Medrad Intego PET Infusion System Pumps

    Bayer is recalling Medrad Intego PET Infusion System pumps because the administration sets may produce particulates in radiopharmaceutical vials.

    Product
    MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1449-2017·2017-02-15

    Circle U Foods Recalls Bayou Seasoning Due to Potential Glass Inclusion

    Circle U Foods, Inc. is recalling 8 cases of Razzoo's/Bayou Seasoning due to a potential glass inclusion hazard.

    Product
    Circle U Foods, Inc. Product Code: 900012 Razzoo's/Bayou Seasoning, RCC/Bayou Seasoning Bag Weight: 0.29 Lbs.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1178-2017·2017-02-15

    Boston Scientific Recalls EMBLEM S-ICD Programmer Model 3200

    Boston Scientific is recalling 4,500 EMBLEM S-ICD Programmer Model 3200 units due to a potential risk of radio frequency interference causing unintended commands during in-clinic sessions.

    Product
    Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1445-2017·2017-02-15

    Annie's Kitchen Vegetable Soup Recalled for Undeclared Wheat Allergen

    Annie's Kitchen is recalling Vegetable Soup because the noodle ingredient contains wheat, which was not declared on the label.

    Product
    Vegetable Soup; Annie's Kitchen; 2966 Stumptown Rd, Ronks, PA 17572 16 FL OZ
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1144-2017·2017-02-15

    Physio-Control Recalls LIFEPAK 15 Defibrillators with Erroneous CO2 Readings

    Physio-Control is recalling LIFEPAK 15 Monitor/Defibrillators with End-Tidal CO2 options because the CO2 reading may intermittently display an incorrect value of XXX.

    Product
    LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2017·2017-02-15

    Stryker Leibinger Recalls Surgical Drainage Accessories Due to Sterility Labeling Error

    Stryker Leibinger is recalling QUINTUBE Monitor Packs and SPG Bulb Drain Systems because non-sterile products were incorrectly labeled as sterile.

    Product
    QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2017·2017-02-15

    Merge RadSuite software recalled due to incorrect pixel value data

    Merge Healthcare is recalling RadSuite software version V8.30.7.8 because incorrect pixel values may lead to patient injury or delayed diagnosis.

    Product
    Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    5 states