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.

25751–25775 of 32212

  • SevereFDA (Devices)·Z-1448-2014·2014-04-16

    Pega Medical Recalls Fassier-Duval Intramedullary Rods Due to Material Defect

    Pega Medical Inc. is recalling five units of the Fassier-Duval IM Telescopic System because the male components were made with material of lower strength than specifications.

    Product
    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1195-2014·2014-04-16

    Terra-Medica Recalls Pleo Not DROPS Due to Penicillin Cross Contamination

    Terra-Medica Inc. is recalling specific batches of Pleo Not DROPS homeopathic medicine due to penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.

    Product
    Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1196-2014·2014-04-16

    Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination

    Terra-Medica Inc. is recalling Pleo Not Portable Sips oral homeopathic medicine due to penicillin cross-contamination. The products were distributed in the US, Canada, and the Philippines.

    Product
    Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1211-2014·2014-04-16

    Terra-Medica Recalls Pleo Ex Portable Sips Due to Penicillin Contamination

    Terra-Medica Inc. is recalling specific batches of Pleo Ex Portable Sips homeopathic medicine due to penicillin cross-contamination.

    Product
    Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1229-2014·2014-04-16

    Glenmark Recalls Ranitidine Tablets Due to Foreign Metoprolol Contamination

    Glenmark Generics Inc. is recalling specific bottles of Ranitidine Tablets USP 150 mg because they were found to contain foreign Metoprolol Tartrate tablets.

    Product
    Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1219-2014·2014-04-16

    Zions RX Formulations Recalls Vitamin B-12 Injections Due to Sterility Concerns

    Zions RX Formulations Services LLC is recalling specific lots of Vitamin B-12 injections due to a lack of assurance of sterility resulting from poor aseptic practices.

    Product
    Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1208-2014·2014-04-16

    Terra-Medica Recalls Pleo Fort Tablets Due to Penicillin Cross Contamination

    Terra-Medica Inc. is recalling Pleo Fort Tablets 5X due to penicillin cross-contamination. The product was distributed nationwide and internationally.

    Product
    Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1200-2014·2014-04-16

    Terra-Medica Recalls Pleo Quent Suppositories Due to Penicillin Contamination

    Terra-Medica Inc. is recalling Pleo Quent Suppositories 3X due to penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.

    Product
    Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1218-2014·2014-04-16

    Zions RX Formulations Recalls Bupivacaine Due to Sterility Concerns

    Zions RX Formulations is recalling 60 units of Bupivacaine 3% in Arizona due to poor aseptic practices that compromised sterility assurance.

    Product
    Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1199-2014·2014-04-16

    Terra-Medica Recalls Pleo Nota-Quent Drops Due to Penicillin Contamination

    Terra-Medica Inc. is recalling Pleo Nota-Quent Drops because of penicillin cross-contamination. The product is distributed in the US, Canada, and the Philippines.

    Product
    Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1197-2014·2014-04-16

    Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination

    Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips oral homeopathic medicine because of penicillin cross-contamination.

    Product
    Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1440-2014·2014-04-16

    Draeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault

    Draeger Medical Systems is recalling three Oxylog 3000 plus ventilators because the control knobs may interrupt contact, causing the device to stop ventilation.

    Product
    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V182000·2014-04-15

    Volkswagen Recalls 2014 Models for Transmission Fluid Leak Fire Risk

    Volkswagen is recalling 2014 Jetta, Beetle, and Passat vehicles because leaking transmission fluid could contact hot surfaces and cause a fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, JETTA, BEETLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E017000·2014-04-15

    Carrier Trailer Refrigeration Units Recalled for Wiring Fire Risk

    Carrier is recalling specific trailer refrigeration units and part kits because a bolt may abrade wiring, increasing the risk of a fire.

    Product
    ELECTRICAL SYSTEM:WIRING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·015-2014-EXP·2014-04-14

    Nutriom LLC Recalls Dried Egg Products Due to Possible Salmonella Contamination

    Nutriom LLC is recalling dried egg products due to possible Salmonella contamination. The recall includes an additional 82,884 pounds of product.

    Product
    Washington Firm Recalls Dried Egg Products Due To Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V195000·2014-04-11

    Open Range LF319 Trailer Recall for Short Kitchen Gas Line

    Open Range is recalling 2014 LF319 fifth wheel trailers because a short gas line in the kitchen slideout may leak when expanded, increasing fire risk.

    Product
    OPEN RANGE — OPEN RANGE LF319
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V171000·2014-04-10

    GM Recalls Vehicles for Ignition Key Removal Defect

    General Motors is recalling specific Saturn, Chevrolet, and Pontiac vehicles because the ignition key can be removed while the engine is running, creating a rollaway risk.

    Product
    SATURN — SATURN, CHEVROLET, PONTIAC ION, COBALT, SOLSTICE, HHR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V176000·2014-04-10

    BMW Recalls 2010-2012 Models for Engine Bolt Failure Risk

    BMW is recalling approximately 156,137 vehicles because VANOS housing bolts may loosen or break, potentially causing the engine to stall and increasing crash risk.

    Product
    BMW — BMW 128I, 135I, 328I, 535I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V189000·2014-04-10

    MV Agusta Recalls 2014 Motorcycles Due to Swingarm Bolt Failure Risk

    MV Agusta is recalling 223 model year 2014 motorcycles because a swingarm bolt may fail, increasing the risk of a crash.

    Product
    MV AGUSTA — MV AGUSTA BRUTALE RR, F3 675, RIVALE 800, F3 800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V168000·2014-04-09

    Toyota and Pontiac Vehicles Recalled for Driver Airbag Cable Defect

    Toyota and General Motors are recalling specific 2006-2010 vehicles because a steering cable defect may prevent the driver's airbag from deploying in a crash.

    Product
    TOYOTA — TOYOTA, PONTIAC TACOMA, YARIS, VIBE, COROLLA MATRIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1189-2014·2014-04-09

    FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source

    American Health Packaging is recalling HydrOXYzine HCl 50 mg tablets because the active ingredient came from an unapproved source.

    Product
    HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1744-2014·2014-04-09

    Net Food Turkey Dried Apricots Recalled for Undeclared Sulfites

    Net Food Import and Export LLC is recalling Turkey Dried Apricots because NYSDAM analysis found undeclared sulfites. The product was distributed in New Jersey.

    Product
    Net Food Turkey Dried Apricots Net Weight 16.1 oz (454 g) Thunderbolt Export & Imports 743 Fairview Avenue. Suit :2 Arcadia, CA 91007 USA UPC 8697445250019
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1724-2014·2014-04-09

    Fresh To Go Tuscan Style Sandwiches Recalled for Undeclared Pine Nuts

    H.C. Schau & Son is recalling Fresh To Go Tuscan Style Combo sandwiches because they contain undeclared pine nuts, a tree nut allergen.

    Product
    8 oz. Tuscan Style Combo on Tomato Basil Spread sandwiches individually wrapped in clear plastic wrap sold under the Fresh To Go brand.
    Category
    Food
    Distribution
    3 states