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.

27651–27675 of 32222

  • SevereFDA (Devices)·Z-2042-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1847-2013·2013-08-28

    Harmony Chai Rooibos Chai Recalled for Improper Processing

    Harmony Chai is recalling 22 oz and 64 oz bottles of decaffeinated Rooibos Chai because the product was not properly processed.

    Product
    Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai Decaffeinated Fresh brewed on Orcas Island, WA Rooibos Chai 22oz. (624,25ml)***Ingredients: water, Organic Raw Sugar, Rooibos Tea, cloves, cinnamon, Ginger, secret spices…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1829-2013·2013-08-28

    NuGo Dark Mint Chocolate Chip Bars Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Mint Chocolate Chip bars because they may contain undeclared milk, posing a risk to people with milk allergies.

    Product
    NuGo Dark Mint Chocolate Chip, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1831-2013·2013-08-28

    NuGo Dark Pretzel Non-Dairy Snack Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Pretzel Non-Dairy snacks because they may contain undeclared milk, a major allergen.

    Product
    NuGo Dark Pretzel 1.59 oz (45g) Non-Dairy Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V383000·2013-08-28

    Toyota Recalls RAV4 and Lexus HS 250h for Rear Suspension Defect

    Toyota is recalling 2006-2011 RAV4 and 2010 Lexus HS 250h vehicles because rear tie rods may fail, causing loss of vehicle control.

    Product
    LEXUS — LEXUS, TOYOTA HS 250 HYBRID, RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1825-2013·2013-08-28

    NuGo Free Dark Chocolate Crunch Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling NuGo Free Dark Chocolate Crunch bars because they may contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    NuGo Free Dark Chocolate Crunch, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1982-2013·2013-08-28

    EndoGastric Solutions Recalls EsophyX2 Devices Due to Tissue Mold Control Loss

    EndoGastric Solutions is recalling EsophyX2 devices because of reports of loss of tissue mold control, which required surgical removal in one case.

    Product
    EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E049000·2013-08-27

    Trans/Air Recalls Compressor Mount Kits for Ford Engines

    Trans/Air is recalling specific Compressor Mount Kits installed on Ford 5.4 or 6.8-liter engines due to a risk of alternator harness damage, vehicle stalling, or fire.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V382000·2013-08-27

    Honda Recalls 2013 Odyssey and Pilot Vehicles for Engine Piston Defect

    Honda is recalling 2013 Odyssey and Pilot vehicles because engine pistons may have insufficient hardness, leading to premature wear and potential engine stalling.

    Product
    HONDA — HONDA ODYSSEY, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-858-2013·2013-08-21

    Pallimed Recalls Alprostadil Injection Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling 408 vials of Alprostadil IN NS Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.

    Product
    Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-884-2013·2013-08-21

    Dr. Reddy's Recalls Ranitidine Tablets Due to Microbial Contamination

    Dr. Reddy's is recalling specific lots of OTC Ranitidine Hydrochloride tablets because raw material tested positive for Pseudomonas sp.

    Product
    Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-886-2013·2013-08-21

    Sanofi Recalls Subpotent Rifadin Capsules Due to Low Fill

    Sanofi-Synthelabo is recalling 998 bottles of Rifadin (rifampin) capsules because some capsules contained less medication than labeled.

    Product
    Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1900-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.

    Product
    Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-857-2013·2013-08-21

    Pallimed Acetylcysteine Ophthalmic Solution Recalled for Sterility Concerns

    Pallimed Solutions is recalling Acetylcysteine Ophthalmic Solution due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-878-2013·2013-08-21

    Pallimed Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Pallimed Solutions is recalling 597 vials of compounded Testosterone Cypionate Injection nationwide due to FDA inspectional findings regarding sterility assurance.

    Product
    Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-866-2013·2013-08-21

    Pallimed Solutions Recalls Dexamethasone PF Due to Sterility Concerns

    Pallimed Solutions is recalling Dexamethasone PF compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1966-2013·2013-08-21

    Medtronic Recalls Pediatric Arterial Filters Due to Potential Media Breach

    Medtronic is recalling 148 Affinity Pediatric Arterial Filters because a small breach in the filter media may allow unwanted particulate or gaseous emboli to pass through, posing a risk of serious injury or death to pediatric patients.

    Product
    Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1902-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1806-2013·2013-08-21

    FOSFOREL Herring Fillet in Oil Recalled for Listeria monocytogenes

    Zip International Group LLC is recalling FOSFOREL brand Herring Fillet in Oil due to the presence of Listeria monocytogenes detected by New York State sampling.

    Product
    FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; refrigerated
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-876-2013·2013-08-21

    Pallimed Solutions Recalls Testosterone Injections Due to Sterility Concerns

    Pallimed Solutions is recalling Testosterone Cypionate/Enanthate injections nationwide due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.

    Product
    Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-880-2013·2013-08-21

    Pallimed Vancomycin Ophthalmic PF Recalled for Sterility Assurance Concerns

    Pallimed Solutions is recalling Vancomycin Ophthalmic PF due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1906-2013·2013-08-21

    Nova Max Plus Monitor System Recalled for False High Glucose Readings

    Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.

    Product
    Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These…
    Category
    Medical Device
    Distribution
    Distributed nationwide