The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

40651–40675 of 50511

  • HighFDA (Food)·F-2306-2014·2014-08-20

    Ronzoni Roasted Garlic Fettuccine Recalled for Undeclared Soy Allergen

    EBRO North America is recalling Ronzoni Roasted Garlic Fettuccine because it may contain undeclared soy, a major food allergen.

    Product
    Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ. Enriched Macaroni Product shelf-stable packed in blue paperboard box all codes
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-2217-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

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

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2014·2014-08-20

    Biomet Recalls Distal Radius Fracture Drill Guides Due to Jig Sticking

    Biomet, Inc. is recalling 37 units of Distal Radius Fracture Repair System drill guides because they become stuck in the jig during use.

    Product
    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2197-2014·2014-08-20

    Gambro Recalls Prisma M 100 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2201-2014·2014-08-20

    Gambro Recalls Prismaflex M60 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M60 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2228-2014·2014-08-20

    Zimmer VER2 Handle Recalled Due to Assembly Failure During Use

    Zimmer, Inc. is recalling 412 units of VER2 Handle, Pin Rework, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 HANDLE, PIN REWORK, LT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V513000·2014-08-20

    Spartan Emergency Vehicles Recalled for Engine Surge Risk

    Spartan is recalling certain 2011-2015 Gladiator and MetroStar emergency vehicles because a software issue may cause engine surges, increasing the risk of personal injury.

    Product
    SPARTAN — SPARTAN GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2312-2014·2014-08-20

    Uncle Ben's Ready Rice Recalled for Undeclared Barley Gluten

    Mars Food US is recalling Uncle Ben's Ready Rice Garden Vegetable pouches because some contain undeclared barley, a gluten source.

    Product
    Uncle Ben's(R) Ready Rice GARDEN VEGETABLE, with PEAS, CARROTS, AND CORN, NET WT. 8.8 OZ (250g), UPC 5480023334
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2014·2014-08-20

    Ortho-Clinical Diagnostics Recalls VITROS CA 19-9 Reagent Packs and Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 19-9 Reagent Packs and Calibrators, Lot 1320, because they may produce positively biased results on specific VITROS systems.

    Product
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2314-2014·2014-08-20

    Interbake Recalls Mrs. Fields Cookies Due to Undeclared Walnuts

    Interbake Foods LLC is recalling specific lots of Mrs. Fields Milk Chocolate Chip Cookies because some cartons contain undeclared walnuts.

    Product
    Mrs. Fields Milk Chocolate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 individually wrapped 1 oz cookies. 12 cartons in a case. UPC 8-86002-50651-7.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2216-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

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

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2014·2014-08-20

    Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of VER2 DBL OFFSET RASP HANDLE, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2014·2014-08-20

    Gambro Recalls Prisma HF1000 Presets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma HF1000 presets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2182-2014·2014-08-20

    Integra Recalls NewPort MIS System Due to Potential Component Mixing

    Integra LifeSciences is recalling four units of the NewPort MIS System because demonstration components may have been mixed with surgical components.

    Product
    Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2220-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handles may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Right Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Right Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2014·2014-08-20

    Brainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error

    Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.

    Product
    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform software recall for alarm mismatch

    Nellcor Puritan Bennett Inc. is recalling Vital Sync software due to a mismatch between alarm priorities on medical devices and the monitoring system.

    Product
    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2193-2014·2014-08-20

    Gambro Recalls Prismaflex TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex TPE 2000 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·14259·2014-08-20

    Attwood Recalls Kayak and Watersports Storage Hangers Due to Injury Hazard

    Attwood is recalling kayak and watersports storage hangers because the length adjustment buckles may release unexpectedly, causing stored items to fall and injure people nearby.

    Product
    Kayak and Watersports Storage Hanger
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2014·2014-08-20

    Medtronic MiniMed Implantable Insulin Pump Recalled for Malfunction

    Medtronic MiniMed is recalling 764 Implantable Insulin Pumps due to reports of pump malfunction causing insulin delivery to stop before the device's 7-year useful life ends.

    Product
    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2194-2014·2014-08-20

    Gambro Recalls Prisma TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.

    Product
    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2229-2014·2014-08-20

    Zimmer Recalls Nonsterile VER2 Handle Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 HANDLE, PIN REWORK, RT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2014·2014-08-20

    Esaote PA230E Ultrasound Transducer Recalled for Excessive Surface Temperature

    Biosound Esaote, Inc. is recalling 1,301 PA230E ultrasound transducers because they may exceed maximum allowable surface temperature limits under specific settings.

    Product
    Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide