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.

39276–39300 of 50506

  • HighFDA (Food)·F-1598-2015·2015-04-01

    Roundy's Original Enchilada Sauce Recalled for Undeclared Peanuts

    Dursett Amigos, Ltd is recalling Roundy's original enchilada sauce due to undeclared peanuts. The product was distributed in Texas, Iowa, North Carolina, and Wisconsin.

    Product
    Roundy's original enchilada sauce Net Wt. 15 oz. (425 g); UPC:011150083492; DISTRIBUTED BY: ROUNDY'S SUPERMARKETS, INC. MILWAUKEE, WI 53201-0473
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1322-2015·2015-04-01

    Ossur Recalls Rheo Knee Bionic Prosthetic Due to Assembly Defects

    Ossur is recalling two Rheo Knee bionic prosthetic units because they were released for distribution without completing the full assembly process.

    Product
    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1310-2015·2015-04-01

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to an issue with photon dose calculation for Dynamic MLC plans.

    Product
    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2015·2015-04-01

    GE x|argos 160D Cabinet X-Ray System Recalled for Shielding Defect

    GE Inspection Technologies is recalling two x|argos 160D cabinet x-ray systems because a lead shield fell out of position, creating potential radiation gaps.

    Product
    GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1593-2015·2015-04-01

    Parade Taco Dinner Kit Recalled for Undeclared Peanuts

    Dursett Amigos, Ltd is recalling Parade Taco Dinner Kits because they contain undeclared peanuts. The recall covers 56 cases distributed in four states.

    Product
    Parade Taco Dinner Kit Includes Shells, Seasoning and Sauce Net Wt. 9.75 oz. (276 g); UPC:050700091518; DISTRIBUTED BY FEDERATED GROUP, INC. 3025 W. SALT CREEK LN. ARLINGTON HEIGHTS, IL 60005
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1317-2015·2015-04-01

    BD Q-Syte Luer Access Split Septum Recalled for Leakage

    Becton Dickinson is recalling BD Q-Syte Luer Access Split Septum units due to complaints of blood or medication leakage caused by silicone septum tearing.

    Product
    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1306-2015·2015-04-01

    Penner Patient Stretcher/Transfer Lift System Recalled for Tipping Hazard

    Penner Mfg Inc is recalling 158 Patient Stretcher/Transfer Lift Systems because improper patient positioning could cause the device to tip, risking injury to patients or operators.

    Product
    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2015·2015-04-01

    Ameda Dual Short Term HygieniKit Milk Collections System Recalled for Lack of Sterilization

    Ameda is recalling its Dual Short Term HygieniKit Milk Collections System because the devices were not sterilized. Consumers should stop using the product and contact the manufacturer.

    Product
    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2015·2015-04-01

    Siemens MAGNETOM MRI Systems Recalled for Gradient Output Supervision Defect

    Siemens Medical Solutions is recalling 132 MAGNETOM MRI systems because a defect in gradient output supervision could allow outputs to exceed safety limits, potentially causing peripheral nerve stimulation.

    Product
    MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2015·2015-04-01

    Flower Orthopedics Recalls Variable Angle Locking Pegs Due to Failure

    Flower Orthopedics is recalling 901 Variable Angle Locking Pegs because they failed to lock during distal radius procedures, resulting in one scheduled revision surgery.

    Product
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1577-2015·2015-04-01

    Uncle Ben's Ready Rice Recalled for Potential Metal Fragments

    Mars Food US is recalling Uncle Ben's Ready Rice New Orleans Style Red Beans & Rice due to the potential for containing metal fragments.

    Product
    UNCLE BEN'S(R) Ready Rice(R) NEW ORLEANS STYLE RED BEANS & RICE, with a blend of smokey, savory seasonings, Net Wt 8.5 oz (240 g),
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2015·2015-04-01

    GE x|tome|x L240 X-ray System Recalled for Lead Shield Defect

    GE Inspection Technologies is recalling two x|tome|x L240 X-ray systems because a lead shield fell out of position, creating potential radiation exposure gaps.

    Product
    GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1628-2015·2015-04-01

    Taj Ethnic Gourmet Punjabi Saag Spinach Sauce Recalled for Undeclared Peanut

    The Hain Celestial Group is recalling Taj Ethnic Gourmet Punjabi Saag Spinach Sauce because it may contain undeclared peanut protein.

    Product
    Taj ETHNIC GOURMET PUNJAB SAAG Spinach Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30013 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1629-2015·2015-04-01

    Food for Lane County Recalls Lentil and Barley Mix for Peanut Contamination

    Food for Lane County is recalling Lentil and Barley dried soup mixes because the included cumin spice packet may contain peanut protein.

    Product
    farm to table meals : Lentil and Barley. This is a dried soup/chili mix which contains lentils and barley in a large zip lock plastic bag along with a small zip lock bag of a chili spice packet. The spice packet contains the recalled cumin. Each plastic zip lock bag has a…
    Category
    Food
    Distribution
    1 state
  • HighCPSC·15106·2015-03-31

    Blinds To Go Recalls Window Shades Due to Strangulation Hazard

    Blinds To Go is recalling about 200,000 custom-made window shades because the cord hold-down device can fail, posing a strangulation risk to small children.

    Product
    Blinds To Go custom-made window shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V188000·2015-03-31

    BMW Recalls 2013-2014 5 Series Vehicles for Rear Reflector Defect

    BMW is recalling certain 2013-2014 5 Series vehicles because rear reflex reflectors may not reflect enough light, increasing crash risk.

    Product
    BMW — BMW 528I, 528XI, 525D XDRIVE, ACTIVE HYBRID 5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V186000·2015-03-30

    Crossroads Recalls 2016 Trailers Due to Slide Room Screw Failure

    Crossroads is recalling 2016 model year recreational trailers because slide room screws may fail, allowing the room to extend while driving and increasing crash risk.

    Product
    CROSSROADS — CROSSROADS SUNSET TRAIL, CRUISER, CRUISER AIRE, CAMEO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V183000·2015-03-30

    MCI Recalls 2007-2010 Motor Coaches Due to Seat Belt Defect

    Motor Coach Industries is recalling 2007-2010 MCI E4500 and J4500 motor coaches because a seat tether bar may interfere with the driver's seat belt locking mechanism.

    Product
    MCI — MCI J4500, E4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V187000·2015-03-30

    Coachmen Prism Recalled for Incorrect Door Component Installation

    Forest River is recalling 2015 Coachmen Prism RVs because an incorrectly installed door component may make doors harder to open after a crash.

    Product
    COACHMEN — COACHMEN PRISM
    Category
    Vehicle
    Distribution
    Distributed nationwide