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.

25251–25275 of 32194

  • SevereFDA (Food)·F-2233-2014·2014-08-06

    Richards Too Good BBQ Sauce Recalled for Botulism Risk

    Richard's Rub & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Hot Sauce, and Teriyaki Sauce due to potential Clostridium botulinum contamination.

    Product
    Richards Too Good BBQ Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V476000·2014-08-04

    Grand Design Recalls 2014 Momentum Trailers Due to Suspension Bolt Defect

    Grand Design is recalling 2014 Momentum 355th, 380th, and 385th fifth wheel trailers because suspension bolts may shear, potentially causing a crash.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM 355TH, MOMENTUM 380TH, MOMENTUM 385TH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V467000·2014-07-31

    Jayco Recalls 2013-2014 Seneca Motorhomes Due to Fire Risk

    Jayco is recalling 2013-2014 Seneca motorhomes because water infiltration into the entrance door keypad may cause corrosion and an electrical short, increasing the risk of a fire.

    Product
    JAYCO — JAYCO SENECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V469000·2014-07-31

    Schwarze M6000SE CNG Street Sweepers Recalled for Fire Risk

    Schwarze is recalling 2009 M6000SE CNG street sweepers because condensation in the intake manifold may freeze, causing sensor failure and potential exhaust fires.

    Product
    SCHWARZE — SCHWARZE M6000SE CNG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1471-2014·2014-07-30

    Trinity Care Solutions Recalls Tobramycin Syringes Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Tobramycin 300 mg/7.5 mL syringes in Florida due to quality control concerns regarding sterility assurance.

    Product
    Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2197-2014·2014-07-30

    Annie Mac's Coconut Macaroons Recalled for Undeclared Allergens

    Annie Mac's Baking Company is recalling Coconut Macaroons because the label fails to declare chocolate, soy lecithin, milk, and sulfur dioxide.

    Product
    Label reads in part "Annie Mac's Baking Co. Coconut Macaroon, "The coconut macaroon is dipped in chocolate, heat sealed in plastic." Net Wt. 12 oz. Product is wrapped in cellophane
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1477-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling 8 units of compounded Cubicin 600 mg/100 mL due to quality control concerns regarding sterility assurance.

    Product
    Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1465-2014·2014-07-30

    Trinity Care Solutions Recalls Impipenem/Cilastin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Impipenem/Cilastin (Primaxin) 500 mg/100 mL due to quality control concerns identified during an FDA inspection.

    Product
    Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #28694, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1464-2014·2014-07-30

    Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling Desferal sterile compounds in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1476-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 543 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1472-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Vancomycin 1 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.

    Product
    Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1470-2014·2014-07-30

    Trinity Care Solutions Recalls ANA Kit Due to Sterility Concerns

    Trinity Care Solutions is recalling ANA Kits due to quality control concerns identified during an FDA inspection regarding the assurance of sterility.

    Product
    ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1458-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 31 units of Ceftriaxone 2 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.

    Product
    Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2068-2014·2014-07-30

    GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure

    GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.

    Product
    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1478-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 700 mg/100 mL due to quality control concerns identified during an FDA inspection.

    Product
    Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2080-2014·2014-07-30

    Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns

    Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.

    Product
    Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2014·2014-07-30

    Trinity Care Solutions Recalls Unasyn Due to Sterility Concerns

    Trinity Care Solutions is recalling 60 units of Unasyn (ampicillin/sulbactam) in Florida due to quality control concerns regarding sterility assurance.

    Product
    Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1457-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling 24 units of Cefepime 2 gm/100 mL D5W in Florida due to quality control concerns regarding sterility assurance.

    Product
    Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1467-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 444 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1461-2014·2014-07-30

    Trinity Care Solutions Recalls Meropenem Due to Sterility Concerns

    Trinity Care Solutions is recalling 42 units of Meropenem 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·14V463000·2014-07-30

    Utility Trailer Recall for Potential Pintle Hook Safety Chain Failure

    Utility Trailer Manufacturing Company is recalling certain 2012-2014 utility trailers because the pintle hook safety chain loop may break, increasing crash risk.

    Product
    UTILITY — UTILITY, UTILITY TRAILER VS1RA, VS2DX, VS2RA, VS3DX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1468-2014·2014-07-30

    Trinity Care Solutions Recalls Normal Saline Syringes Due to Sterility Concerns

    Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
    Category
    Medical Device
    Distribution
    1 state