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.

33451–33475 of 50502

  • HighFDA (Drugs)·D-0264-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Infuvite IV Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 161 vials of Infuvite IV compounded between May and November 2016 because the agency cannot assure the products are sterile.

    Product
    Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0350-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits

    Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin injectable kits due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0278-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Nandrolone Decanoate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 701 vials of Nandrolone Decanoate 200 mg/ml because the agency could not ensure the products were sterile.

    Product
    Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2017·2017-01-11

    Interventional Spine Recalls G3 Opticage Expandable Interbody Fusion Devices

    Interventional Spine Inc is recalling 239 G3 Opticage Expandable Interbody Fusion Devices because the proximal end may separate during implantation, preventing the device from expanding.

    Product
    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2017·2017-01-11

    Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association

    Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0342-2017·2017-01-11

    Wells Pharmacy Recalls B-Complex Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling B-complex + Vit C injectable vials due to a lack of assurance of sterility.

    Product
    B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0382-2017·2017-01-11

    Wells Pharmacy Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 526 vials of compounded Nandrolone Decanoate injectable nationwide due to a lack of assurance of sterility.

    Product
    Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1167-2017·2017-01-11

    Elmec Industries Recalls 20 oz Pudding for Undeclared Wheat and Soy

    Elmec Industries is recalling 20 oz pudding containers in Puerto Rico due to undeclared wheat and soy allergens.

    Product
    Label reads in part as: "Ced¿ Pud¿n***Keep Refrigerated***NET WT 20 OZ (566 g)***Manufactured and Packed by Elmec Industries Inc.***229 Guanajibo Rd. Mayaguez, P.R. 00681".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0947-2017·2017-01-11

    Aesculap Recalls Gomco Circumcision Clamps Due to Excessive Bleeding Reports

    Aesculap Implant Systems LLC is recalling 437 units of Gomco Circumcision Clamps nationwide after receiving complaints of excessive bleeding following use.

    Product
    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17065·2017-01-10

    Michaels Recalls Rock Salt Lamps Due to Shock and Fire Hazards

    Michaels is recalling about 80,000 Lumière brand rock salt lamps because the dimmer switch or outlet plug can overheat, posing shock and fire risks.

    Product
    Rock Salt Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-010717·2017-01-07

    Chicken Strips May Be Contaminated with Listeria, USDA Says

    USDA FSIS issued a public health alert about ready-to-eat chicken breast strips produced by House of Raeford on Sept. 29, 2016 that may be contaminated with Listeria monocytogenes. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert For Chicken Strips Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·17V007000·2017-01-06

    Kia Recalls One 2016 Optima for Driver Air Bag Defect

    Kia is recalling one 2016 Optima because the driver's frontal air bag inflator seal may not be installed properly, potentially reducing inflation in a crash.

    Product
    KIA — KIA OPTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-010617·2017-01-06

    USDA FSIS Public Health Alert: Sliced Deli Meat May Contain Listeria

    USDA FSIS issued a public health alert for sliced deli meat products produced by Peter DeFries Corporation between Dec. 14 and Dec. 29, 2016, due to possible Listeria monocytogenes contamination. The products were distributed to Dion's restaurant locations in Colorado, New Mexico, and Texas.

    Product
    FSIS Issues Public Health Alert For Sliced Deli Meat Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1083-2017·2017-01-04

    Publix Pumpkin Pancake Mix Recalled Due to Salmonella Risk

    Publix is recalling Premium Pumpkin Pancake & Waffle Mix because the milk powder ingredient may contain Salmonella.

    Product
    Publix Premium Pumpkin Pancake & Waffle Mix, 16 oz box.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1039-2017·2017-01-04

    Sunset Natural Products Recalls Blanc Dietary Supplement Under Consent Decree

    Sunset Natural Products Inc. is recalling Blanc Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.

    Product
    Blanc Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0919-2017·2017-01-04

    Siemens Recalls SOMATOM Scope CT Systems for Power Cutout Risk

    Siemens is recalling 13 SOMATOM Scope CT systems to replace a component that could cause a power cutout during use.

    Product
    SOMATOM Scope, Computed tomography x-ray system
    Category
    Medical Device
    Distribution
    10 states
  • HighCPSC·17063·2017-01-04

    Disney Recalls Infant Hoodies Due to Choking Hazard from Detaching Snaps

    Walt Disney Parks and Resorts is recalling Minnie and Mickey Mouse infant hoodie sweatshirts because the snaps can detach, posing a choking hazard to young children.

    Product
    Minnie and Mickey Mouse infant hoodie sweatshirts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2017·2017-01-04

    Allen Medical Systems Recalls Arthex S3 Arm Sleeve Connectors

    Allen Medical Systems is recalling 420 Arthex S3 Arm Sleeve Connectors because they may separate unexpectedly during use, potentially causing moderate injury to patients.

    Product
    Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
    Category
    Medical Device
    Distribution
    1 state