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.

36826–36850 of 50507

  • HighFDA (Devices)·Z-0626-2016·2016-01-20

    Encore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature

    Encore Medical is recalling 23 AltiVate Reverse Humeral Broaches because the trial shell mating feature is undersized. The instruments are used with Encore Shoulder prostheses.

    Product
    AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0624-2016·2016-01-20

    Nipro Medical Recalls Hemodialysis Blood Tubing Sets Due to Foaming

    Nipro Medical Corporation is recalling 1,484 disposable hemodialysis blood tubing sets because blood foaming was found during product evaluation.

    Product
    NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0652-2016·2016-01-20

    Intuitive Surgical Recalls da Vinci Xi 8mm Endoscopes for Safety Manual Correction

    Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to prevent unintended patient harm from capacitive coupling when using 8mm endoscopes with specific instruments.

    Product
    0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16E003000·2016-01-20

    GMAX Recalls GM78 Fullface Helmets for Safety Standard Non-Compliance

    GMAX Helmet LLC is recalling specific GM78 Fullface helmets that may not adequately protect users in a crash. Owners can exchange the helmet or receive a refund.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0653-2016·2016-01-20

    Intuitive Surgical Recalls da Vinci Xi Endoscopes for Capacitive Coupling Risk

    Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to warn about unintended patient harm from capacitive coupling when using 8 mm endoscopes with specific instruments.

    Product
    30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0422-2016·2016-01-20

    Mi Tienda Tostada Siveria Large Tostada Recalled for Metal Fragments

    HEB Retail Support Center is recalling Mi Tienda Tostada Siveria Large Tostada due to possible metal fragments. The product was sold in Texas.

    Product
    Mi Tienda Tostada Siveria Large Tostada packaged in bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0421-2016·2016-01-20

    Mi Tienda Masa Preparada Recalled for Possible Metal Fragments

    HEB Retail Support Center is recalling Mi Tienda Masa Preparada By the Pound due to the possible presence of metal fragments.

    Product
    Mi Tienda Masa Preparada By the Pound packaged in bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0567-2016·2016-01-20

    Freedom Pharmaceuticals Recalls Domperidone API Due to Penicillin Cross-Contamination

    Freedom Pharmaceuticals is recalling specific lots of Domperidone API for prescription compounding due to potential cross-contamination with penicillin.

    Product
    Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2016·2016-01-20

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0502-2016·2016-01-20

    Sweet Leaf Organic Raspberry Iced Tea Recalled for Glass Particles

    Nestle Waters North America is recalling Sweet Leaf Organic Raspberry Iced Tea because the product contains glass particles.

    Product
    Sweet Leaf Organic Raspberry Iced Tea, 16 oz glass bottle UPC: 6-51538-06703-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V022000·2016-01-20

    Setra Recalls 2011-2012 Buses Due to Missing Seat Belt Welds

    Setra is recalling 2011-2012 S407CC and S417TC buses because missing welds on seat brackets could cause seat belts to detach during a crash.

    Product
    SETRA — SETRA S407 CC, S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0505-2016·2016-01-20

    Nestle Recalls Sweet Leaf Citrus Green Tea Due to Glass Particles

    Nestle Waters North America is recalling Sweet Leaf All Natural Citrus Green Tea because the product contains glass particles.

    Product
    Sweet Leaf All Natural Citrus Green Tea, 16 oz glass bottle UPC: 6-51538-06720-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2016·2016-01-20

    Bayer Recalls Medrad Source Administration Sets for Dosing Errors

    Bayer Healthcare is recalling Medrad Source Administration Sets because tubing defects may cause incorrect dose positioning during nuclear medicine procedures.

    Product
    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2016·2016-01-20

    Mercury Medical Recalls Neo-Tee T-Piece Resuscitators Due to Occlusion Risk

    Mercury Medical is recalling Neo-Tee T-Piece Resuscitators and circuits because incorrect use can cause complete circuit occlusion, leading to failure to ventilate the patient.

    Product
    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2016·2016-01-20

    Skytron Ergon 2 Monitor Brackets Recalled Due to Hardware Failure Risk

    Skytron is recalling 286 Ergon 2 monitor brackets because hardware may fail, causing displays to fall and potentially injure patients or providers.

    Product
    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment…
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0642-2016·2016-01-20

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0565-2016·2016-01-20

    Amerisource Recalls Hydrochlorothiazide Capsules Due to Particulate Matter

    Amerisource Health Services is recalling specific lots of Hydrochlorothiazide capsules because they contain particulate matter.

    Product
    HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2016·2016-01-20

    ArthroCare Cavity 8 Gauge Spine Wand Recalled for Sterile Barrier Failure

    ArthroCare Corporation is recalling 262 Cavity 8 Gauge Spine Wands because cracking in the tray compromises the sterile barrier.

    Product
    Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16077·2016-01-19

    West Elm Recalls Saddle Bar and Counter Stools Due to Fall Hazard

    West Elm is recalling Saddle bar and counter stools because the legs can break, posing a fall hazard. The firm received six reports of breaking, including one injury.

    Product
    Saddle bar and counter stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E002000·2016-01-19

    Mazda CX-5 Windshield Recall Due to Improperly Affixed Sensor Bracket

    Pilkington is recalling replacement windshields for Mazda CX-5 vehicles because the Smart City Brake Support sensor bracket may loosen, potentially disabling safety features.

    Product
    MAZDA — MAZDA CX-5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V018000·2016-01-19

    Suzuki Recalls Motorcycles Due to Electrical System Defect

    Suzuki is recalling certain 2008-2012 motorcycles because a faulty regulator/rectifier may cause the engine to stall while riding, increasing crash risk.

    Product
    SUZUKI — SUZUKI VLR1800, DL1000, GSX1300R, GSF1250S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·006-2016·2016-01-16

    Kayem Foods Recalls Chicken Sausage Due To Misbranding And Undeclared Pork

    Kayem Foods Inc. is recalling approximately 22,182 pounds of chicken sausage products due to incorrect nutritional labeling and undeclared pork casings.

    Product
    Kayem Foods Inc. — Kayem Foods Inc. Recalls Chicken Sausage Products Due To Misbranding
    Category
    Food
    Distribution
    Distributed nationwide