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.

25176–25200 of 32194

  • SevereFDA (Drugs)·D-1555-2014·2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling compounded fentanyl infusion bags distributed in Texas and Georgia because the supplier recalled the source fentanyl due to loose or missing vial crimps.

    Product
    fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive…
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1547-2014·2014-08-27

    Hospira Recalls Propofol Vials Due to Metallic Particulate Matter

    Hospira Inc. is recalling 844,300 vials of Propofol Injectable Emulsion because glass defects allowed metallic particulates to enter the solution.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2256-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2335-2014·2014-08-27

    Natural Grocers Recalls Organic Chunks of Energy Carob Supergreens for Salmonella Risk

    Natural Grocers by Vitamin Cottage is recalling Organic Chunks of Energy Carob Supergreens due to the potential presence of Salmonella.

    Product
    Natural Grocers Organic Chunks of Energy Carob Supergreens, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1549-2014·2014-08-27

    Doctor's Best Red Yeast Rice Recalled for Undeclared Lovastatin

    Doctor's Best is recalling Red Yeast Rice 1200 capsules because FDA analysis found undeclared lovastatin, making it an unapproved new drug.

    Product
    Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E056000·2014-08-26

    Agility Fuel Systems Recalls CNG Fuel Hoses Due to Corrosion Risk

    Agility Fuel Systems is recalling specific CNG fuel systems because a hose component may corrode and leak gas, increasing fire risk.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V517000·2014-08-26

    NABI Transit Bus Recall for CNG Fuel Tank Abrasion Risk

    NABI is recalling 2012-2014 31LFW and 40LFW transit buses because CNG fuel tanks may be abraded by pressure relief devices, increasing fire risk.

    Product
    NABI — NABI 40LFW, 31LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V516000·2014-08-26

    Audi Recalls 2013 Q7 Vehicles Due to Brake Booster Oil Leak Risk

    Volkswagen is recalling 2013 Audi Q7 vehicles with 3.0L TDI engines because engine oil may leak into the brake booster, potentially causing a loss of power braking assist.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V514000·2014-08-22

    Ford Recalls 2014 Focus and C-Max for Steering Gear Assembly Defect

    Ford is recalling 2014 Focus and C-Max vehicles manufactured in August 2014 due to incorrectly assembled steering gears that may cause loss of steering control.

    Product
    FORD — FORD C-MAX, FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E055000·2014-08-20

    Thermo King Inverters Recalled for Fire Risk in Tractor Cabins

    Thermo King is recalling specific 1100W, 1500W, and 2000W inverters sold between May and July 2014 because they may spark or overheat, posing a fire hazard.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2230-2014·2014-08-20

    Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.

    Product
    23.5 Deg Rasp Handle Assy- LEFT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2225-2014·2014-08-20

    Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2313-2014·2014-08-20

    Farmers Market Recalls Shelled Walnuts for Listeria Contamination Risk

    Farmers Market is recalling 8 oz. packages of shelled walnuts due to potential Listeria monocytogenes contamination.

    Product
    Shelled walnuts, 8 oz., packed in a clear plastic container and sold under the Farmer's Market brand.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2177-2014·2014-08-20

    Carestream Recalls Kodak DirectView DR 7500 X-Ray Systems Due to Loose Parts

    Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.

    Product
    Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2135-2014·2014-08-20

    Enhancement Medical Recalls Injectable Gel Due to Production Process Change

    Enhancement Medical is recalling 17,875 units of EXP-150 Injectable Gel because a production change altered the final gel weight. The recall covers all lots distributed in the US and Canada.

    Product
    Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2203-2014·2014-08-20

    Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.

    Product
    Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2155-2014·2014-08-20

    Cardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System

    Cardiovascular Systems, Inc. is recalling 48 Diamondback 360 Peripheral Orbital Atherectomy Systems because the saline sheath may crack or fracture, releasing particulate during use.

    Product
    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2209-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk

    Medical Positioning Inc is recalling two Model # 1019 HUT tables due to a component defect that may cause the table to drop into the Trendelenburg position more rapidly than normal.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2202-2014·2014-08-20

    Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2199-2014·2014-08-20

    Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1538-2014·2014-08-20

    Teva Recalls Carbidopa and Levodopa Tablets Due to Potential Superpotency

    Teva Pharmaceuticals USA is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg, due to the potential for superpotent tablets.

    Product
    Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
    Category
    Drug
    Distribution
    Distributed nationwide