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.

25251–25275 of 50443

  • HighFDA (Devices)·Z-2102-2019·2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor

    Terumo is recalling 52 Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.

    Product
    Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2120-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding

    Burlington Medical is recalling two radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.

    Product
    1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Sleeves Due to Inadequate Shielding

    Burlington Medical is recalling 39 radiation protection sleeves because the material may provide inadequate protection against scatter radiation.

    Product
    Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2019·2019-08-07

    Burlington Medical Recalls Overlap Vests Due to Potential Inadequate Radiation Protection

    Burlington Medical is recalling seven Overlap Vests because the protective material may provide inadequate protection against scatter radiation.

    Product
    Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2019·2019-08-07

    Burlington Medical Recalls Lead Apron Products Due to Inadequate Radiation Protection

    Burlington Medical is recalling 332 lead apron products because the protective material may provide inadequate protection against scatter radiation.

    Product
    2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2019·2019-08-07

    Burlington Medical Recalls Frontal Stretch Buckle Closure Aprons

    Burlington Medical is recalling nine Frontal Stretch Buckle Closure Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1963-2019·2019-08-07

    Dolfin Dark Chocolate Recalled for Undeclared Milk Allergen

    Dolfin S.A. is recalling Dark Chocolate with Pink Peppercorns because the product may contain undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Dolfin Dark Chocolate with Pink Peppercorns Net Wt 2.47 oz (70g), UPC 5 413415 233300, bar code 1938090025
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2091-2019·2019-08-07

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.

    Product
    Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1952-2019·2019-08-07

    Green Giant Fresh Butternut Squash Recalled for Listeria Risk

    Growers Express is recalling Green Giant Fresh Butternut Squash Diced due to a positive Listeria monocytogenes test result.

    Product
    Green Giant Fresh Butternut Squash Diced. 12 oz. (340 g) plastic bag UPC: 605806138010; Item number BNC101101 Perishable, Keep Refrigerated Distributed by Growers Marketing LLC, Salinas, CA
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2109-2019·2019-08-07

    Burlington Medical Frontal Support Belt Apron Recalled for Inadequate Radiation Protection

    Burlington Medical is recalling six Frontal Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1961-2019·2019-08-07

    Growers Express and Peak Cauliflower Florets Recalled for Listeria Risk

    Growers Express and Peak cauliflower florets are recalled after a positive Listeria monocytogenes test result from a Massachusetts retail sample.

    Product
    Growers Express Cauliflower Florets 3 lb. plastic bag - Foodservice UPC: 190627-405616; Item numberCAC102102 Peak Cauliflower Florets 3 lb. plastic Bag - foodservice UPC: 190628-405842, Item Number CAC102105 Perishable, Keep Refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1962-2019·2019-08-07

    Growers Express and Peak Cauliflower Florets Recalled for Listeria Risk

    Growers Express and Peak cauliflower florets are being recalled after a positive Listeria monocytogenes test result was found in a random sample.

    Product
    Growers Express Cauliflower Florets 3 lb. plastic bag - Foodservice UPC: 190627-405616; Item numberCAC102102 Peak Cauliflower Florets 3 lb. plastic Bag - foodservice UPC: 190628-405842, Item Number CAC102105 Perishable, Keep Refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2131-2019·2019-08-07

    GE Senographe Pristina Mammography Systems Recalled for Biopsy Positioner Slippage

    GE Healthcare is recalling 82 Senographe Pristina mammography systems because the biopsy positioner may slip when the gantry is rotated during a procedure.

    Product
    GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2019·2019-08-07

    Burlington Medical Recalls Frontal Quick Drop OR Aprons Due to Radiation Risk

    Burlington Medical is recalling 23 Frontal Quick Drop OR Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1950-2019·2019-08-07

    Green Giant Cauliflower Sweet Potato Crumbles Recalled for Listeria

    Growers Express is recalling Green Giant Cauliflower Sweet Potato Crumbles after a positive Listeria monocytogenes test result was found in a retail sample.

    Product
    Green Giant Fresh Cauliflower Sweet Potato Crumbles; Chopped Sweet Potato and Cauliflower 1 lb.(16 oz.) (454 g) plastic bag UPC: 605806000515; Item number MXC100101 Perishable, Keep Refrigerated Distributed by Growers Marketing LLC, Salinas, CA
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1953-2019·2019-08-07

    Green Giant Fresh Butternut Squash Recalled for Listeria Risk

    Growers Express is recalling Green Giant Fresh Butternut Squash Cubed due to a positive Listeria monocytogenes test result from a retail sample.

    Product
    Green Giant Fresh Butternut Squash Cubed. 32 oz. (2 lbs.) (907 g) plastic bag UPC: 605806138218; Item number BNC102101 Perishable, Keep Refrigerated Distributed by Growers Marketing LLC, Salinas, CA
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2101-2019·2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Arterial Thermistor

    Terumo is recalling 16 Capiox NX19 Oxygenators with a non-functioning arterial thermistor component. The units were distributed in Michigan, Japan, and Belgium.

    Product
    Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2125-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding

    Burlington Medical is recalling 48 radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.

    Product
    Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F Product Usage: Products are designed to protect healthcare workers against scatter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2019·2019-08-07

    Burlington Medical Recalls Frontal Apron Velcro Closures Due to Radiation Protection Concerns

    Burlington Medical is recalling 104 Frontal Apron Velcro Closures because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, UEF17XXLM Product Usage: Products are designed to protect healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2019·2019-08-07

    Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

    Burlington Medical is recalling 2,190 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.

    Product
    Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP Product Usage: Products are designed to protect healthcare workers against scatter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1945-2019·2019-08-07

    Truly Good Foods Edamame Beans Recalled for Missing Allergen Statement

    Tropical Nut & Fruit Company is recalling Truly Good Foods Edamame Beans because the label is missing the required allergen statement.

    Product
    Truly Good Foods Edamame Beans Roasted and Salted 7 oz. (198g) plastic clam shell DISTRIBUTED BY TRULY GOOD FOODS, CHARLOTTE, NC 28273 UPC 0 94184 56100 6
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-2089-2019·2019-08-07

    Wilson-Cook Medical Recalls Acuject Variable Injection Needles

    Wilson-Cook Medical is recalling Acuject Variable Injection Needles due to a potential for occluded needles. The affected units were distributed to China.

    Product
    Acuject Variable Injection Needle
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2132-2019·2019-08-07

    GE Pristina Serena Breast Biopsy Accessory Recalled for Slippage Risk

    GE Healthcare is recalling 16 Pristina Serena breast biopsy accessories because the positioner may slip when the machine rotates during a procedure.

    Product
    GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2019·2019-08-07

    Burlington Medical Recalls Full Wrap Support Belt Aprons Due to Radiation Risk

    Burlington Medical is recalling 51 Full Wrap Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2019·2019-08-07

    Burlington Medical Recalls Seven Peak Vests Due to Inadequate Radiation Protection

    Burlington Medical is recalling seven Peak Vests because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.

    Product
    Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount…
    Category
    Medical Device
    Distribution
    Distributed nationwide