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.

18501–18525 of 32106

  • SevereFDA (Devices)·Z-0866-2017·2016-12-28

    Northgate Technologies Recalls Laparoscopic Insufflators Due to Overpressure Risk

    Northgate Technologies is recalling 49 laparoscopic insufflators because they may cause patient overpressure without visual or auditory warnings.

    Product
    Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0902-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes Due to Listeria Risk

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

    Product
    **1) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #5075810 8449874; **2) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #50758108449904; **3) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **4) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **5) 1 GL CVF FRUIT SALAD…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0219-2017·2016-12-28

    US Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination

    US Compounding Inc is recalling 10,665 Docusate Oral 10 mg/mL syringes distributed in Texas due to microbial contamination with B. cepacia.

    Product
    Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0226-2017·2016-12-28

    Amgen Recalls Kyprolis Vials Due to Potential Glass Cracks

    Amgen is recalling 11,434 vials of Kyprolis (carfilzomib) injection because potential cracks in the glass vials may compromise sterility.

    Product
    KYPROLIS — KYPROLIS (CARFILZOMIB)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0726-2017·2016-12-28

    Woodland Foods Recalls Salt-Free Roasted Sunflower Seeds for Listeria Risk

    Woodland Foods is recalling D'Allesandro Salt-Free Roasted Sunflower Seeds due to potential Listeria contamination. The product was distributed to food distributors in 26 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "D'ALLESANDRO SALT-FREE ROASTED SUNFLOWER SEEDS". Product was packaged into 5 & 40 lb boxes.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Drugs)·D-0222-2017·2016-12-28

    3rd Degree Capsules Recalled for Undeclared Sibutramine

    Making It a Lifestyle is recalling 3rd Degree capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

    Product
    3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0213-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in both superpotent and subpotent doses.

    Product
    Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2017·2016-12-28

    Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

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

    Product
    C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0942-2017·2016-12-28

    Interbake Foods Recalls Girl Scout Peanut Butter Sandwiches Due to Aflatoxin

    Interbake Foods is recalling Girl Scout Peanut Butter Sandwiches because a single lot of peanut butter used contained elevated aflatoxin levels.

    Product
    Girl Scout Peanut Butter Sandwich, NET WT 8 0Z (227 g). UPC 0 20200 07007 8, ABC Bakers/Interbake Foods LLC, Richmond, VA 23233.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0777-2017·2016-12-28

    Wakefern Recalls Chocolate Dipped Cookies Due to Metal Pieces

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

    Product
    Gourmet Chocolate Dipped Cookies Net Wt. 46 oz UPC 269969414994
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0766-2017·2016-12-28

    Chaos and Pain Recalls Cannibal Ferox Amped Pre-Workout Supplement

    Chaos and Pain is recalling its Cannibal Ferox Amped pre-workout supplement because it contains an undeclared prohibited substance.

    Product
    CANNIBAL FEROX AMPED, FACE-MELTING NOOTROPIC, PRE-WORKOUT ENERGY COMPLEX, STRAWBLOODY KIWI CRUSH, DIETARY SUPPLEMENT, NET. WT. 9.9 OZ (280g), Chaos and Pain, UPC 1056331460
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0762-2017·2016-12-28

    Naturecom Recalls DMAA Powder Due to Potential Presence of 1,3-Dimethylamylamine

    Naturecom is recalling 500g bags of DMAA powder because the product may contain 1,3-dimethylamylamine. The recall covers products distributed nationwide and internationally.

    Product
    DMAA (1,3-Dimethylamylamine) Net Weight 500g Product is packaged in approximately 8" x 11 silver and clear mylar ziplock bags that contain 500g of DMAA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0768-2017·2016-12-28

    Coliman Pacific Recalls Jalapeno Peppers Due to Salmonella Contamination Risk

    Coliman Pacific Corp is recalling jalapeno peppers because they may be contaminated with Salmonella. The affected product was distributed in California and Arizona.

    Product
    Jalapeno Peppers, 40lbs (19 kg) per case, 1 1/9 Bushel Box, 49 cases per pallet
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0782-2017·2016-12-28

    FDA Recalls Ultroid Hemorrhoid Management Systems for Quality System Deficiencies

    The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.

    Product
    Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
    Category
    Medical Device
    Distribution
    34 states
  • 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