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.

40251–40275 of 50511

  • HighCPSC·15016·2014-10-30

    Tectron Recalls 3-in-1 USB Phone Chargers Due to Fire Hazard

    Tectron International is recalling 3-in-1 USB phone chargers because they can overheat and pose a fire hazard. Two incidents of melting were reported, with no injuries or property damage.

    Product
    3-in-1 USB phone charger
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2015·2014-10-29

    Siemens Symbia E SPECT Systems Recalled for Loose Bolts in Detector Support

    Siemens Medical Solutions is recalling 562 Symbia E SPECT systems due to reports of loose bolts in the detector support structure.

    Product
    Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-0040-2015·2014-10-29

    Venus Wafers Recalls PC Organics Crackers for Undeclared Sesame

    Venus Wafers Inc. is recalling PC Organics Original Stoned Wheat Crackers because the product contains undeclared sesame seeds.

    Product
    President's Choice- PC Organics brand Original Stoned Wheat Crackers, 200 g UPC: 0 60383 70928 0
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0098-2015·2014-10-29

    DeRoyal SafeLiner Suction Canister Kit Recalled for Insufficient Seal

    DeRoyal Industries is recalling 5,112 units of SafeLiner Suction Canister Kits due to an insufficient seal under low or intermittent suction conditions.

    Product
    DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0110-2015·2014-10-29

    Mortara Surveyor S12 and S19 Patient Monitors Recalled for Mounting Hazard

    Mortara Instrument is recalling 624 Surveyor S12 and S19 patient monitors due to a potential safety hazard when mounted with non-standard screws.

    Product
    Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2015·2014-10-29

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-Ds and TELIGENT ICDs due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2015·2014-10-29

    Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion

    Boston Scientific is recalling TELIGEN ICDs and COGNIS CRT-Ds due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2015·2014-10-29

    Siemens e.cam Gamma Camera Systems Recalled for Loose Bolts

    Siemens Medical Solutions is recalling e.cam gamma camera systems due to reports of loose bolts in the detector support structure.

    Product
    e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0090-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Tubing Leak Risk

    Codman & Shurtleff is recalling 93,558 EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2015·2014-10-29

    Zimmer Persona Tibial Articular Surface Inserter Recalled for Deformation Risk

    Zimmer, Inc. is recalling 618 units of the Persona Tibial Articular Surface Inserter because they did not undergo heat treatment, creating a risk of tip deformation.

    Product
    The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0046-2015·2014-10-29

    Next by Nature Dark Chocolate Cherries Recalled for Undeclared Peanuts

    Tropical Valley Foods is recalling Next by Nature Dark Chocolate Cherries because the product may contain undeclared peanuts.

    Product
    next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Plattsburgh, NY 12901
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0097-2015·2014-10-29

    DeRoyal and Novaplus Suction Canisters Recalled for Insufficient Seal

    DeRoyal Industries is recalling 13,900 non-sterile suction canisters and lids because they may have an insufficient seal under low or intermittent suction conditions.

    Product
    Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.

    Product
    Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision

    Siemens is recalling ADVIA Centaur HBc Total kits due to increased imprecision and positive bias that may cause false reactive results.

    Product
    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0027-2015·2014-10-29

    R.M. Palmer Recalls Creepy Peepers Caramel Balls for Undeclared Peanut

    R.M. Palmer Company is recalling Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs because the product contains undeclared peanut butter.

    Product
    soft caramel balls coated in chocolate in orange plastic bag with labeling: palmer Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs NET WT 9 OZ Creepy Peepers Lot/Code Date: 066113 UPC 00041269503734 MANUFACTURED ON EQUIPMENT WHICH PROCESSES WHEAT, PEANUT…
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0056-2015·2014-10-29

    Plum Organics Little Cremes Recalled for Choking Hazard in Infants

    Plum, Inc. is recalling Little Cremes rice milk snacks because they are not softening as intended, posing a choking hazard to babies and young children.

    Product
    Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Greens: Kale, Apple and Sweet Potato; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC APPLE PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0058-2015·2014-10-29

    Plum Organics Little Cremes Recalled for Choking Hazard in Infants

    Plum, Inc. is recalling Little Cremes organic rice milk snacks because they are not softening as intended, posing a choking hazard to babies and young children.

    Product
    Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Reds: Pomegranate, Beet and Berry; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients:ORGANIC SWEET POTATO PUREE, ORGANIC STRAWBERRY PUREE, ORGANIC POMEGRANATE JUICE CONCENTRATE, ORGANIC RICE…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2015·2014-10-29

    DePuy Synthes Radiolucent Retractor Recalled for Adhesive Tape Residue

    Synthes, Inc. is recalling 11 DePuy Synthes Radiolucent Retractors due to adhesive tape residue that poses a risk of tissue or systemic reactions.

    Product
    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0059-2015·2014-10-29

    Multiple Organics Recalls Organic Mango Fillets Due to Potential Metal Fragments

    Multiple Organics is recalling 687 cartons of organic mango fillets because they may contain metal fragments that could injure consumers if ingested.

    Product
    Outer Carton labeled in part as: Multiple Organics Certified 100% Organic Mango Fillets Net Weight 20 Lbs. (9.07 kgs) In 5 X 4 Lb. bags Product of Mexico Certified Organic by QAI www.multipleorganics.com USDA Organic Inner plastic bag labeled in part as: Organic…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0113-2015·2014-10-29

    Vygon Recalls Bionector Needleless Connectors Due to Membrane Elasticity Issues

    Vygon is voluntarily recalling Bionector Needleless connectors due to potential problems with membrane elasticity. The recall affects 42,250 units distributed worldwide.

    Product
    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0105-2015·2014-10-29

    Philips Avalon Fetal Monitors Recalled for Software Measurement Error

    Philips is recalling Avalon fetal monitors with specific software because automatic blood pressure measurements stop in certain modes.

    Product
    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2015·2014-10-29

    Philips IntelliVue Monitors Recalled for NBP Measurement Stoppage

    Philips is recalling IntelliVue monitors with specific software revisions because the automatic blood pressure measurement series stops in time-synchronized mode.

    Product
    Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms…
    Category
    Medical Device
    Distribution
    Distributed nationwide