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.

25601–25625 of 32194

  • SevereFDA (Devices)·Z-1542-2014·2014-05-14

    Med-Mizer RetractaBed Recall for Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse or rollers to detach.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1546-2014·2014-05-14

    Alere INRatio2 Test Strips Recalled for Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio2 PT/INR Professional Test Strips because they may report inaccurately low INR results, potentially affecting warfarin therapy monitoring.

    Product
    Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V252000·2014-05-14

    GM Recalls 2004-2012 Vehicles for Electronic Stability Control Defect

    General Motors is recalling 2004-2012 Chevrolet, Pontiac, and Saturn vehicles because a wiring issue can disable crash avoidance features like traction control.

    Product
    CHEVROLET — CHEVROLET, SATURN, PONTIAC MALIBU, AURA, G6, MALIBU MAXX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V255000·2014-05-14

    Lodal Recalls 2011-2013 Evo Garbage Trucks Due to Fire Risk

    Lodal is recalling 2011-2013 Evo garbage trucks because condensation in the intake manifold may freeze, causing sensor issues that increase the risk of vehicle fire or burn injury.

    Product
    LODAL — LODAL EVO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2014·2014-05-14

    Medtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk

    Medtronic is recalling SynchroMed II implantable drug infusion pumps because they may overinfuse medication, potentially causing life-threatening overdose or drug withdrawal.

    Product
    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1543-2014·2014-05-14

    Med-Mizer RetractaBed Recall Due to Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling 2,980 RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1565-2014·2014-05-14

    SpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage

    SpineFrontier is recalling S-Lift Lock Shaft Inserters because the impact cap or pin may break during spinal surgery, potentially releasing fragments into the sterile field.

    Product
    SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V247000·2014-05-14

    GM Recalls 2014 Chevrolet Malibu for Brake Vacuum Assist Loss

    General Motors is recalling specific 2014 Chevrolet Malibus because a software issue may cause a complete loss of brake vacuum assist, increasing stopping distance.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1559-2014·2014-05-14

    Teleflex Medical Recalls Bard Fixt Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.

    Product
    Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • SevereNHTSA·14V244000·2014-05-13

    Supreme Corporation Recalls 2013 Transit Buses Due to Wheelchair Lift Fire Risk

    Supreme Corporation is recalling 116 model year 2013 transit buses and trolleys because an armored cable may not clear the wheelchair lift, posing a fire risk.

    Product
    STARTRANS — STARTRANS, SUPREME PRESIDENT, SENATOR II, ACTIVITY, SENATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V248000·2014-05-13

    Jerr-Dan Standard Duty Wreckers Recalled for Underlift Boom Drift

    Jerr-Dan is recalling 2007-2014 Standard Duty Wreckers because the underlift boom tilt cylinder may drift down during towing, increasing crash risk.

    Product
    JERR-DAN — JERR-DAN STANDARD DUTY WRECKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V240000·2014-05-08

    GM Recalls 2014 Buick Lacrosse and Chevrolet Malibu for Brake Defect

    General Motors is recalling 2014 Buick Lacrosse and Chevrolet Malibu vehicles because incorrect front brake rotors may cause brake pad detachment and reduced braking.

    Product
    CHEVROLET — CHEVROLET, BUICK MALIBU, LACROSSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1263-2014·2014-05-07

    Medisca Recalls Human Chorionic Gonadotropin Due to Labeling Error

    Medisca Inc. is recalling specific lots of Human Chorionic Gonadotropin (HCG) because the labels contain erroneous potency information.

    Product
    Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1266-2014·2014-05-07

    B. Braun Recalls Ceftriaxone Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling Ceftriaxone for Injection and Dextrose Injection due to visible particulate matter found in reserve sample units.

    Product
    Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1265-2014·2014-05-07

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve sample units.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1264-2014·2014-05-07

    B. Braun Recalls Cefoxitin and Dextrose Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling Cefoxitin and Dextrose injectable products due to visible particulate matter found in reserve sample units.

    Product
    CEFOXITIN AND DEXTROSE — CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1260-2014·2014-05-07

    John W Hollis Inc Recalls Polidocanol 3% Solution Due to Particulate Matter

    John W Hollis Inc is recalling 3 vials of Polidocanol 3% Solution due to the presence of particulate matter. The product was distributed in Missouri, Tennessee, Mississippi, and Wisconsin.

    Product
    Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1274-2014·2014-05-07

    B. Braun Recalls ProcalAmine Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling ProcalAmine injectable products due to visible particulate matter found in reserve samples.

    Product
    ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1271-2014·2014-05-07

    B. Braun Recalls FreAmine HBC Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 6.9% FreAmine HBC (Amino Acid Injection) units due to visible particulate matter found in reserve samples.

    Product
    6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1267-2014·2014-05-07

    B. Braun Recalls Cefepime Injection Due to Visible Particulate Matter

    B. Braun Medical Inc. is recalling Cefepime Hydrochloride and Dextrose injection units because visible particulate matter was found in reserve samples.

    Product
    CEFEPIME HYDROCHLORIDE AND DEXTROSE — CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1513-2014·2014-05-07

    Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error

    Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.

    Product
    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET…
    Category
    Medical Device
    Distribution
    7 states