The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

17101–17125 of 29206

  • SevereFDA (Food)·F-0900-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL CVF FRUIT SALAD DELUXE IN GRAPE JUICE, UPC 50758108455745
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0784-2017·2016-12-28

    Wakefern Sugar Cookies Recalled for Potential Metal Contamination

    Wakefern Food Corp. is recalling 24-count sugar cookies due to the potential presence of metal pieces. The product was distributed in six states.

    Product
    24CT Sugar Cookies Net Wt. 24oz UPC 208719004191
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0887-2017·2016-12-28

    Amendia Recalls Black Widow Spinal Screws Due to Mating Feature Defect

    Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2017·2016-12-28

    Baxter Recalls Fluconazole Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 30,910 bags of Fluconazole Injection due to confirmed customer complaints of leaking bags, which compromises sterility.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0832-2017·2016-12-28

    Samuel Adams Apple Hard Cider Recalled for Bottle Bursting Risk

    Samuel Adams Brewery is recalling Apple Orchard Crisp Apple Hard Cider because bottles may burst due to re-fermentation.

    Product
    Apple Orchard Crisp Apple Hard Cider Three packages sizes: ¿ Loose case = 24  12 oz bottles ¿ 12 pack = 12  12 oz bottles, shipped as 2  12 packs per case ¿ 4  6 pack = 6  12 oz bottles per pack, shipped as 4  6 packs per case
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Devices)·Z-0889-2017·2016-12-28

    Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise

    Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.

    Product
    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0780-2017·2016-12-28

    Wakefern Recalls Take&Bake Sugar Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling 24-count Take&Bake Sugar Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24CT Take&Bake Sugar Cookies Net Wt. 24oz UPC 208906004195
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0878-2017·2016-12-28

    Merge OrthoCase software recall due to measurement errors

    Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.

    Product
    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0217-2017·2016-12-28

    Novo Nordisk Recalls GlucaGen HypoKits Due to Detached Needles

    Novo Nordisk is recalling 71,215 GlucaGen HypoKits because the syringe needles may be detached. The recall covers lots expiring in September 2017.

    Product
    GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0212-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate sublingual tablets because they failed content uniformity specifications, resulting in tablets that are either superpotent or subpotent.

    Product
    Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2017·2016-12-28

    Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-PAV/PHENTOL/ATROP/PGE1 injectable products due to lack of assurance of sterility. The recall affects products distributed in New Jersey and New York.

    Product
    C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0776-2017·2016-12-28

    Wakefern Recalls Dipped Chocolate Chip Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling Dipped Chocolate Chip Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    Dipped Chocolate Chip Cookies Net Wt. 24 oz UPC 269954004995
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0227-2017·2016-12-28

    Meta Pharmacy Recalls Compounded Eye Drops Due to Sterility Concerns

    Meta Pharmacy Services is recalling Phenylephrine and Tropicamide compounded eye drops due to a lack of sterility assurance. The affected product was distributed to one consignee in Las Vegas.

    Product
    Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0775-2017·2016-12-28

    Wakefern Recalls Kid's Rainbow Sprinkled Cookie Platter Due to Metal Pieces

    Wakefern Food Corp. is recalling Kid's Rainbow Sprinkled Cookie Platters because they may contain metal pieces. The product was distributed in six states.

    Product
    Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0746-2017·2016-12-28

    Midwest International Recalls Low Acid Canned Fish Without Registered Process

    Midwest International Corp is recalling low acid canned fish products that lack a registered manufacturer and scheduled process. The recall covers distribution in eight states.

    Product
    Qiejidingxiangyu, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0785-2017·2016-12-28

    Wakefern Recalls 24-Count Candy Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling 24-Count Candy Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24CT Candy Cookies Net Wt. 24oz UPC 208713004197
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·16V952000·2016-12-27

    Southwest Trailer-Mounted Generators Recalled for Tongue Separation Risk

    Southwest is recalling 2013-2016 QP25, QP35, and QP45/50 trailer-mounted generators because the trailer tongue may separate, creating a road hazard.

    Product
    SOUTHWEST — SOUTHWEST QP45/50 GENERATOR, QP25 GENERATOR, QP35 GENERATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V949000·2016-12-23

    DRV Recalls 2016-2017 Elite and Mobile Suites Due to Brake Bolt Issue

    DRV Suites is recalling 2016-2017 Elite and Mobile Suites fifth wheel trailers because brake caliper bolts may loosen, potentially causing a loss of braking capability.

    Product
    DRV — DRV MOBILE SUITE, ELITE SUITES ALL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V929000·2016-12-23

    Mack Trucks Recalls Front Wheel Hubs on Pinnacle, Granite, and Titan Models

    Mack is recalling certain 2012-2017 trucks because front wheel hubs may fail, potentially causing loss of vehicle control or dropped parts.

    Product
    MACK — MACK PINNACLE (CXU), GRANITE (GU), PINNACLE (CHU), TITAN (TD)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V923000·2016-12-22

    Pierce Recalls 2015-2016 Dash CF Emergency Vehicles Due to Fire Risk

    Pierce Manufacturing is recalling 2015-2016 Dash CF emergency vehicles because a defective bracket may damage the starter motor, increasing the risk of a fire.

    Product
    PIERCE — PIERCE DASH CF
    Category
    Vehicle
    Distribution
    Distributed nationwide