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.

15776–15800 of 29205

  • SevereFDA (Drugs)·D-0976-2017·2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 221 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0953-2017·2017-07-19

    Advanced Pharma Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Advanced Pharma Inc. is recalling QUELICIN (Succinylcholine Chloride) Injection due to a lack of assurance of sterility. The recall affects 2,350 units distributed nationwide.

    Product
    QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0954-2017·2017-07-19

    Advanced Pharma Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 72 units of Potassium Phosphate IV bags nationwide due to a lack of assurance of sterility.

    Product
    Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0955-2017·2017-07-19

    Advanced Pharma Recalls Potassium Phosphate Bags Due to Sterility Concerns

    Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride bags because the company cannot assure the product's sterility.

    Product
    Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V457000·2017-07-18

    Mazda Recalls CX-7, CX-9, and Mazda6 for Air Bag Inflator Rupture Risk

    Mazda is recalling specific 2007-2012 CX-7, CX-9, and Mazda6 vehicles because the passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    MAZDA — MAZDA CX-7, MAZDA6, CX-9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E038000·2017-07-18

    TriMark Recalls Ambulance Door Striker Bolts for Crash Safety Non-Compliance

    TriMark is recalling specific door striker bolts used in ambulance door systems because they may fail during a crash, causing doors to open and increasing injury risk.

    Product
    STRUCTURE:BODY:DOOR:HINGE AND ATTACHMENTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V454000·2017-07-17

    Thomas Built Buses Saf-T-Liner C2 Recalled for Wheelchair Anchorage Defect

    Daimler Trucks North America is recalling 2005-2018 Thomas Built Buses Saf-T-Liner C2 transit buses because the wheelchair pocket track anchorage may not secure a wheelchair in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V451000·2017-07-17

    Freightliner Custom Chassis XCR Recalled for Battery Cable Fire Risk

    Daimler Trucks North America is recalling 2014-2017 Freightliner Custom Chassis XCR vehicles because an improperly installed battery cable bracket may cause a short circuit and fire.

    Product
    FCCC — FCCC, FREIGHTLINER CUSTOM CHASS XCR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·082-2017·2017-07-15

    Marathon Enterprises Recalls Hot Dogs Due to Bone Fragment Contamination

    Marathon Enterprises is recalling approximately 7.2 million pounds of hot dog products due to potential bone fragment contamination. One minor oral injury has been reported.

    Product
    Marathon Enterprises Inc. — Marathon Enterprises Inc. Recalls Hot Dog Products Due to Possible Extranous Material Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V447000·2017-07-14

    Mercedes-Benz Recalls 2017 Smart Fortwo Vehicles for Steering Knuckle Defect

    Mercedes-Benz USA is recalling 2017 Smart Fortwo and Cabriolet vehicles because casting imperfections in the left front axle steering knuckle could cause failure and increase crash risk.

    Product
    SMART — SMART FORTWO, FORTWO CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V444000·2017-07-14

    Keystone Recalls 2016-2018 Avalanche Trailers Due to Tire Hazard

    Keystone RV Company is recalling 2016-2018 Avalanche recreational trailers because a kitchen slide-out bolt could contact the front tire, potentially causing sudden tire failure and increasing crash risk.

    Product
    KEYSTONE — KEYSTONE AVALANCHE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0940-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling 72,575 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2424-2017·2017-07-12

    Smucker Foods Recalls Durum Atta Flour for Potential E. coli Contamination

    Smucker Foods of Canada Co. is recalling specific brands of Durum Atta Flour due to potential E. coli contamination reported by a co-packer.

    Product
    Flour sold under the following brands: Golden Temple Durum Atta Flour Blend, 20LB, DISTRIBUTED BY: SMUCKER FOODS OF CANADA CORP., MARKHAM, ON L3R 0P3 PRODUCT OF CANADA UPC 0 59000 41556 7, Swad Durum Atta Flour, 20 LB MILLED FOR: RAJA FOODS 8110 N. St. Louis Avenue Skokie, IL…
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0946-2017·2017-07-12

    Fagron Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    Fagron Compounding Services is voluntarily recalling 1,056 syringes of Succinylcholine Chloride because the company cannot ensure the product is sterile.

    Product
    Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling specific lots of Clindamycin Injection USP due to a lack of assurance of sterility. The recall covers 71,825 vials distributed nationwide.

    Product
    Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0949-2017·2017-07-12

    Phillips Recalls Diabecline Topical Ointment Due to Manufacturing Deviations

    Phillips Co. is recalling Diabecline brand Topical Ointment First Aid Antibiotic because FDA inspections found significant manufacturing deviations that question the product's safety and quality.

    Product
    Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2437-2017·2017-07-12

    Bulletproof Fudge Brownie Collagen Protein Bites Recalled for Listeria Risk

    Bulletproof 360 Inc is recalling Fudge Brownie Collagen Protein Bites due to potential Listeria monocytogenes contamination. The recall covers products sold nationwide and internationally.

    Product
    Fudge Brownie Collagen Protein Bite. Each Bite is packed in foil wrapper, net wt. per Bite 0.74 oz (21g). There 15 pieces packed in a box and the net wt. is 11.10 oz (315 g). Individual Bar UPC 815709021528. Box UPC 815709021535.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0952-2017·2017-07-12

    Phillips Co. Recalls VenomX Zinc Acetate Skin Protectant Due to GMP Deviations

    Phillips Co. is recalling VenomX Zinc Acetate Skin Protectant because FDA inspections found manufacturing practices that question the product's safety and quality.

    Product
    VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2657-2017·2017-07-12

    CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes

    CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.

    Product
    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user…
    Category
    Medical Device
    Distribution
    Distributed nationwide