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.

13826–13850 of 29188

  • SevereNHTSA·18V536000·2018-08-15

    Volkswagen Recalls Passat and Atlas for Brake Caliper Bolt Issue

    Volkswagen is recalling 2017-2018 Passat and 2018 Atlas vehicles because brake caliper bracket bolts may be loose, potentially reducing braking ability.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ 160/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2675-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, Size 3. 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-1065-2018·2018-08-15

    Guardian Pharmacy Recalls Ropivacaine HCl ON-Q Pumps for Sterility Concerns

    Guardian Pharmacy Services is recalling 25 units of Ropivacaine HCl 2 mg/mL 550 mL ON-Q Pumps due to a lack of sterility assurance. The products were distributed in Texas.

    Product
    Ropivacaine HCl 2 mg/mL 550 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-2712-2018·2018-08-15

    Howmedica Recalls #3 Bipolar Radial Head Implant Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #3 Bipolar radial head Implant (Sterile packed). 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-1062-2018·2018-08-15

    Guardian Pharmacy Recalls Methylene Blue Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 95 vials of Methylene Blue 10 mg/mL in 1 mL syringes due to a lack of sterility assurance. The product was distributed in Texas.

    Product
    Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1054-2018·2018-08-15

    Guardian Pharmacy Recalls B-Complex Due to Lack of Sterility Assurance

    Guardian Pharmacy Services is recalling B-Complex products in 100 mL bags and vials due to a lack of sterility assurance. The affected units were distributed in Texas.

    Product
    B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2716-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.

    Product
    #2 Bipolar stem implant (Sterile packed). 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-1069-2018·2018-08-15

    Guardian Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 250 syringes of Lidocaine 3% in Texas due to a lack of sterility assurance.

    Product
    Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2736-2018·2018-08-15

    FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints

    Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.

    Product
    iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1061-2018·2018-08-15

    Guardian Pharmacy Recalls Medroxyprogesterone Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 60 vials of compounded Medroxyprogesterone 150 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1771-2018·2018-08-15

    YWAM Faith Harvest Helpers Recalls Canned Salmon Due to Process Violation

    YWAM Faith Harvest Helpers is recalling 4,818 cans of salmon because the firm lacked a scheduled process for manufacturing low-acid canned food.

    Product
    Canned Salmon in unlabeled 8oz metal cans. Cans are packaged into a case of 92 cans. The case label is read: "Canned Salmon***Product of U.S.A. Net. Wt. 62 lbs. Packed by: Faith Harvest Helpers 12643 Case Rd SW Olympia, WA 98512***"
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1122-2018·2018-08-15

    World Organix Recalls Blissful Remedies Red Maeng Da Capsules for Microbial Contamination

    World Organix, LLC is recalling Blissful Remedies Red Maeng Da capsules due to potential high microbial loads. The recall covers 789 pouches distributed nationwide.

    Product
    Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2660-2018·2018-08-15

    Arjohuntleigh Magog Quick Connect 272 KG Scale Recall for Detachment Risk

    Arjohuntleigh Magog is recalling Quick Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.

    Product
    Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2686-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, Size 2. 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-1055-2018·2018-08-15

    Guardian Pharmacy Recalls EDTA Disodium Syringes for Sterility Concerns

    Guardian Pharmacy Services is recalling EDTA Disodium 30 mg/mL pre-filled syringes due to a lack of sterility assurance. The product was distributed in Texas.

    Product
    EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2685-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns

    Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, 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-1056-2018·2018-08-15

    Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 2,400 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Glutathione 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-1052-2018·2018-08-15

    Guardian Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 4,900 vials of Ascorbic Acid 500 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2738-2018·2018-08-15

    Datex-Ohmeda Neonatal Flow Sensor Cable Recall for Missing Connector Housing

    Datex-Ohmeda is recalling 417 Neonatal Flow Sensor Cables because the connector housing may be missing, exposing internal wires. The defect poses a risk of electrical shock or fire.

    Product
    The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1073-2018·2018-08-15

    Guardian Pharmacy Recalls Phenol 6% Injection Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 40 vials of Phenol 6% with Glycerin Injection in Texas due to a lack of sterility assurance.

    Product
    Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1067-2018·2018-08-15

    Guardian Pharmacy Recalls Cefazolin Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling Cefazolin 2 Gm/20 mL syringes in Texas due to a lack of sterility assurance.

    Product
    Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1745-2018·2018-08-15

    Whole Foods Recalls Lemon Raspberry Cake for Undeclared Soy

    Whole Foods Market is recalling Lemon Raspberry Cake made in Mid-Atlantic stores because it failed to declare soy flour as an ingredient.

    Product
    CAKE LEMON RASPBERRY
    Category
    Food
    Distribution
    0 states