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.

34826–34850 of 50502

  • HighCPSC·16258·2016-09-08

    HAUS Mosquito Zapper LED Bulbs Recalled for Electrical Shock Hazard

    Creative Sourcing is recalling HAUS ZapBulb mosquito zapper LED light bulbs because the base can separate from the connector, posing an electrical shock hazard.

    Product
    ZapBulb mosquito zapper LED light bulbs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 2,574 diamond coated tips and burs because the labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2713-2016·2016-09-07

    Cardinal Health Recalls Arterial Blood Gas Kits Missing Safety Clasp

    Cardinal Health is recalling specific lots of 9025TRU Arterial Blood Gas Kits because they are missing a locking clasp component, posing a potential safety risk.

    Product
    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2016·2016-09-07

    Teleflex Recalls MAQUET Servo Humidifier 163 Units Due to Connector Cracking

    Teleflex Medical is recalling 2,700 MAQUET Servo Humidifier 163 units because the ISO female connector may crack. The units were distributed to Florida, Kansas, and West Virginia.

    Product
    MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2709-2016·2016-09-07

    Merge Cardio software recall due to incorrect patient data saving

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because reports may be saved to incorrect patient records.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V645000·2016-09-07

    Forest River Recalls 2017 Coachmen Viking Trailers Due to Roof Strut Defect

    Forest River is recalling 2017 Coachmen Viking recreational trailers because a missing wire clip may allow the roof strut to detach, causing the roof to drop and increasing injury risk.

    Product
    COACHMEN — COACHMEN VIKING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2004-2016·2016-09-07

    Republic of Tea Organic Turmeric Ginger Green Tea Recalled for Salmonella

    Republic of Tea is recalling Organic Turmeric Ginger Green Tea because the supplier reported a positive Salmonella result in the organic ginger ingredient.

    Product
    The Republic of Tea - Organic Turmeric Ginger: Green Tea Ingredients: Organic Turmeric, Organic Green Tea, Organic Ginger, Organic Cinnamon and Natural Honey Flavor Packed in 250 CT Bulk Bag (375 g) and and 50 count refill bag. (75 g) UPC - 250 bulk bag: 7-42676-30655-9…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2691-2016·2016-09-07

    Elekta Recalls HexaPOD evo RT Systems for Positioning Errors

    Elekta is recalling 13 HexaPOD evo RT Systems because the treatment couch may not move fully to the correct 3D position, potentially leading to unrecognized positioning errors during radiotherapy.

    Product
    HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2003-2016·2016-09-07

    Republic of Tea Recalls Organic Turmeric Ginger Green Tea Due to Salmonella

    Republic of Tea is recalling Organic Turmeric Ginger Spice of Life Green Tea because a supplier reported a positive Salmonella result in the organic ginger used.

    Product
    Organic Turmeric Ginger Spice of Life Green Tea; Organic Blend of Tumeric, Spices, Natural Honey Flavor and Fine China Green Tea 50 CT Tin: Net Wt. 2.65 oz.. (75G) UPC: 7-42676-40355-5. The Republic of Tea
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2671-2016·2016-09-07

    GE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors

    GE Healthcare is recalling Centricity Laboratory software versions 3.3 to 4.1 because deleting a slave panel incorrectly removes free-text notes and reference ranges from the master panel.

    Product
    Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2708-2016·2016-09-07

    Alcon AcrySof IQ Intraocular Lens Recall Due to Delivery System Defect

    Alcon is recalling specific lots of AcrySof IQ intraocular lenses because the ULTRASERT delivery system may cause the lens to become lodged during implantation.

    Product
    Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2678-2016·2016-09-07

    DeRoyal Recalls Custom Surgical Kits Due to Sterility Concerns

    DeRoyal Industries is recalling 26 custom surgical kits containing Bard Toomey Irrigation Syringes due to a possible package defect that may affect sterility.

    Product
    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2688-2016·2016-09-07

    Invivo Breast MRI Auxiliary Table Recalled Due to Missing Diode

    Invivo Corporation is recalling three breast MRI auxiliary tables because a missing diode may cause the coil to overheat.

    Product
    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2704-2016·2016-09-07

    Siemens ADVIA Chemistry XPT Recall for A1c Calculation Error

    Siemens is recalling ADVIA Chemistry XPT systems due to a software error that causes falsely low Hemoglobin A1c results in IFCC units.

    Product
    ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1992-2016·2016-09-07

    Tippins Cream Cheese Pie Base Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 60 cases of 9-inch cream cheese pie bases because they may contain low levels of peanut residue.

    Product
    Tippins 9" Cream Cheese Base packaged in ?. UPC code is 680816002711. Packaged in 18 pie bases per case. Shipped frozen.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2679-2016·2016-09-07

    DeRoyal recalls two custom surgical kits with potential sterility defect

    DeRoyal Industries Inc is recalling two custom surgical kits containing a BARD Toomey Irrigation Syringe due to a possible package slit that may affect sterility.

    Product
    DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1998-2016·2016-09-07

    Wonder Meal Recalled for Undeclared Milk Allergen

    FKC International is recalling Wonder Meal bottles due to undeclared milk from whey protein. Consumers with milk allergies should not consume the product.

    Product
    Wonder Meal Net Weight 455 grams 15.75 oz UPC Code: 6 03808 12813
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2689-2016·2016-09-07

    Mindray A7 Anesthesia Delivery System Recalled for Potential Oxygen Leak

    Mindray is recalling 167 A7 Anesthesia Delivery Systems due to a potential leak on the back-up oxygen and air cylinder yokes.

    Product
    A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1994-2016·2016-09-07

    Tippin's Key Lime Pie Bases Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 8-inch Key Lime Pie Bases because they may contain low levels of peanut residue. The product was distributed to seven states.

    Product
    Tippins 8" Key Lime Base packaged in ?. UPC code is 680816001851. Packaged in 12 pie bases per case. Shipped frozen. Net wt. 21oz each.
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·16C007000·2016-09-07

    Evenflo Recalls Evolve 3-in-1 Booster Seats Due to Harness Loosening Risk

    Evenflo is recalling specific Evolve 3-in-1 Combination Booster Seats because children can access a button to loosen the harness, increasing injury risk in a crash.

    Product
    CHILD SEAT:HARNESS:STRAP/WEBBING recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2670-2016·2016-09-07

    Philips Recalls UNIQ 1.0 Fluoroscopy Systems Due to Power Supply Failures

    Philips is recalling 1,536 UNIQ 1.0 fluoroscopy systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2016·2016-09-07

    Integra Recalls Spinal Trays Due to Lidocaine Component Issue

    Integra LifeSciences is recalling specific lots of Spinal Trays because they contain affected Hospira 5% Lidocaine HCL.

    Product
    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1993-2016·2016-09-07

    Tippin's Keylime Pie Bases Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 60 cases of 9-inch Keylime Pie Bases because they may contain low levels of peanut residue.

    Product
    Tippins 9" Keylime Base packaged in ?. UPC code is 680816000205. Packaged in 18 pie bases per case. Shipped frozen. Net wt. 31oz each.
    Category
    Food
    Distribution
    7 states