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.

13776–13800 of 29188

  • SevereFDA (Devices)·Z-2589-2018·2018-08-22

    Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk

    Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.

    Product
    Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2791-2018·2018-08-22

    Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure

    Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.

    Product
    VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1098-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan 320mg Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling 14 bottles of Valsartan 320mg tablets distributed in Indiana because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1084-2018·2018-08-22

    Ranier's PR/PA/PH Injection Recalled for Sterility Concerns

    Ranier's Compounding Laboratory is recalling PR/PA/PH Injection vials due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1095-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity

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

    Product
    Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1094-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Papaverine/Phentolamine Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Papav 300/Phent 5mg/10mL Injection due to lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1100-2018·2018-08-22

    RemedyRepack Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

    Product
    Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1083-2018·2018-08-22

    Ranier's Triple P Injection Recalled for Sterility Assurance Concerns

    Ranier's Compounding Laboratory is recalling Triple P Injection due to practices that may call into question the sterility of the product.

    Product
    Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1078-2018·2018-08-22

    alba BOTANICA Sunscreen Recalled for Microbial Contamination

    The Hain Celestial Group is recalling alba BOTANICA Sensitive Sheer Shield Sunscreen SPF 50+ due to microbial contamination. Consumers should stop using the product.

    Product
    alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2825-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing

    Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.

    Product
    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2799-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1080-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Atropine 0.01% Opth Solution

    Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution due to a lack of assurance of sterility. The product was distributed within Pennsylvania.

    Product
    Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1091-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls PRASH Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling PRASH Injection vials because practices at the firm may call into question the sterility of the product.

    Product
    PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1093-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls P/P/P Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling P/P/P Injection vials because practices at the firm may call into question the sterility of the product.

    Product
    P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1101-2018·2018-08-22

    RemedyRepack Recalls Valsartan 160 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 160 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1081-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls DMSO 6.25% Opth Sol for Sterility Concerns

    Ranier's Compounding Laboratory is recalling DMSO 6.25% Opth Sol due to a lack of assurance of sterility. The product was distributed within Pennsylvania.

    Product
    DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V554000·2018-08-22

    Volvo Recalls 2019 XC40 Vehicles Due to Brake Pedal Rivet Defect

    Volvo is recalling 2019 XC40 vehicles because brake pedals may not be correctly riveted, potentially reducing braking performance and increasing crash risk.

    Product
    VOLVO — VOLVO XC40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2793-2018·2018-08-22

    NxStage Express Fluid Warmer Recalled for Electrical Fire Risk

    NxStage Medical is recalling Express Fluid Warmers due to a potential risk of electrical fire if fluid leaks into the power receptacle.

    Product
    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1086-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Dehydrated Alcohol Solution Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Dehydrated Alcohol Solution vials because practices at the firm may call into question the sterility of the products.

    Product
    Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1089-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Acetylcysteine 10% Ophthalmic Solution

    Ranier's Compounding Laboratory is recalling Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1097-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan 80mg Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling Valsartan 80mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1102-2018·2018-08-22

    RemedyRepack Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·18198·2018-08-21

    Confer Plastics Recalls Pool Step Systems Due to Entrapment Hazard

    Confer Plastics is recalling Curve in-pool step systems because children's limbs can become entrapped in side openings, posing a drowning risk.

    Product
    Curve in-pool step systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide