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.

13801–13825 of 29188

  • SevereNHTSA·18V551000·2018-08-21

    Nissan and Chevrolet Recall for Ignition Switch Stalling Risk

    Nissan is recalling 2017-2018 models including the Versa, Sentra, and NV200 because the ignition switch may shift, causing the engine to stall and increasing crash risk.

    Product
    NISSAN — NISSAN, CHEVROLET VERSA NOTE, NV200 TAXI, VERSA, CHEVEROLET SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V548000·2018-08-20

    Ford Recalls 2018-2019 Vehicles for Electrical Arc Fire Risk

    Ford is recalling 2018-2019 Edge, Flex, MKX, and MKT vehicles because improperly secured power supply cables may cause an electrical arc, increasing the risk of a fire.

    Product
    LINCOLN — LINCOLN, FORD MKT, FLEX, EDGE, MKX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V545000·2018-08-17

    2019 Coachmen Freedom Express Recalled for Brake Wiring Defect

    Forest River is recalling 2019 Coachmen Freedom Express trailers because the break-away safety switch may not engage brakes if the trailer detaches.

    Product
    COACHMEN — COACHMEN FREEDOM EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V546000·2018-08-17

    Winnebago Recalls 2016-2019 Motorhomes Due to Unfused Solar Charging Circuit

    Winnebago is recalling 2016-2019 motorhomes because an unfused auxiliary solar charging circuit can increase the risk of fire if solar panels exceed the circuit's amperage capacity.

    Product
    WINNEBAGO — WINNEBAGO TREND, PASEO, JOURNEY, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V539000·2018-08-16

    Mercedes-Benz Recalls 2018 GLE and GLS Models for Brake Defect

    Mercedes-Benz is recalling 9,044 2018 GLE and GLS vehicles because rear brake caliper pistons may release gas, reducing braking performance.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLE43, GLS 450, AMG GLE63S, GLS 550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V542000·2018-08-16

    Volvo Recalls 2019 VNL and VNR Trucks for Fifth Wheel Defect

    Volvo is recalling 2019 VNL and VNR trucks because a narrow fifth wheel bracket may allow the trailer to separate from the tractor, increasing crash risk.

    Product
    VOLVO — VOLVO VNL, VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V543000·2018-08-16

    Mack Recalls 2019 Anthem Trucks Due to Fifth Wheel Bracket Defect

    Mack Trucks is recalling 2019 Anthem trucks with Jost fifth wheel couplings because a narrow slider bracket may allow the trailer to separate, increasing crash risk.

    Product
    MACK — MACK ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1063-2018·2018-08-15

    Guardian Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 300 syringes of Fentanyl Citrate 50 mcg/mL in Texas due to a lack of sterility assurance.

    Product
    Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2553-2018·2018-08-15

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk

    Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.

    Product
    AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric…
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Drugs)·D-1058-2018·2018-08-15

    Guardian Pharmacy Recalls Hyaluronidase Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling Hyaluronidase 150 units/mL vials in Texas due to a lack of sterility assurance.

    Product
    Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1123-2018·2018-08-15

    World Organix Recalls Blissful Remedies Herbal Shot Due to Microbial Contamination

    World Organix, LLC is recalling Blissful Remedies 4 Hour Chill herbal shots due to potential high microbial loads. The affected products were distributed nationwide.

    Product
    Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1071-2018·2018-08-15

    Guardian Pharmacy Recalls Methylcobalamin Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 2,000 vials of compounded Methylcobalamin 1000 mcg/mL in Texas due to a lack of sterility assurance.

    Product
    Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1060-2018·2018-08-15

    Guardian Pharmacy Recalls Magnesium Sulfate Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 1,000 vials of Magnesium Sulfate 200 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1068-2018·2018-08-15

    Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling specific lots of compounded Glutathione 200 mg/mL vials in Texas due to a lack of sterility assurance.

    Product
    Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1070-2018·2018-08-15

    Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 100 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1124-2018·2018-08-15

    World Organix Recalls Blissful Remedies Liquid Kratom for Microbial Contamination

    World Organix, LLC is recalling Blissful Remedies Red Maeng Da Liquid Kratom due to potential high microbial loads. The product was distributed nationwide in the USA.

    Product
    Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V530000·2018-08-15

    KZRV Connect Recalled for Propane Line Fire Risk

    KZRV is recalling 2018-2019 Connect trailers because liquid propane lines routed through the wheel well may be damaged by road debris, increasing fire risk.

    Product
    KZRV — KZRV CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1046-2018·2018-08-15

    Akorn Recalls Lidocaine and Prilocaine Cream Due to Impurity

    Akorn, Inc. is recalling Lidocaine 2.5% and Prilocaine Cream because routine stability testing found an unknown impurity.

    Product
    Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1051-2018·2018-08-15

    Guardian Pharmacy Recalls Morphine Sulfate CADD Due to Sterility Concerns

    Guardian Pharmacy Services is recalling specific lots of compounded Morphine Sulfate 1 mg/mL CADD 25 mL due to a lack of sterility assurance.

    Product
    Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V532000·2018-08-15

    Winnebago and Itasca Motorhomes Recalled for Propane Hose Leak Risk

    Winnebago is recalling 2012-2013 Era, View, Via, Itasca Navion, and Reyo motorhomes because high-pressure propane hoses may harden and leak, increasing fire risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIEW, REYO, VIA, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2018·2018-08-15

    Pharmalucence Recalls Technetium TC 99M Medronate Kits Due to Sterility Breach

    Pharmalucence, Inc. is recalling 95 kits of Technetium TC 99M Medronate due to a reported breach of sterility. The affected product is distributed nationwide.

    Product
    KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE — KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1066-2018·2018-08-15

    Guardian Pharmacy Recalls Ropivacaine HCl Due to Sterility Concerns

    Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL 750 mL ON-Q Pumps due to a lack of sterility assurance. The affected product was distributed in Texas.

    Product
    Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2681-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant 6mm Collar Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1064-2018·2018-08-15

    Guardian Pharmacy Recalls Ropivacaine HCl Due to Sterility Concerns

    Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL in ON-Q Pumps due to a lack of sterility assurance. The affected product was distributed in Texas.

    Product
    Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1059-2018·2018-08-15

    Guardian Pharmacy Recalls Hyaluronidase Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 442 syringes of Hyaluronidase 150 units/mL in Texas due to a lack of sterility assurance.

    Product
    Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state